Universal Small Fragment System System Tutorial

FOR USE WITH OPERATING ROOM STAFF

118841-190717 DSUS 8/19

Introduction The Universal Small Fragment System is intended to be used for small bone trauma, including anatomy such as Shoulder, Clavicle, Elbow, Tibia and Fibula. The core set can support any DePuy Synthes 2.7mm or 3.5mm non-locking, LCP® or VA LCP ® Implant System1 Training topics for USF • System Trays • Instruments 1. Universal Small Fragment Surgical Technique Guide

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Universal Small Fragment (USF) System System Trays

✓ Core Set ✓ Anatomic Implant Trays

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Instruments

✓ Drill Guides ✓ Drill Bits ✓ Depth Gauge ✓ Handle and Driver Shafts ✓ Bending Irons ✓ Periosteal Elevator

Core Set Key Points Graphic Case Standard Plate Tray

Auxiliary Tray

Screw Rack

Insertion Instruments Tray

– No new implants introduced with this product release. – The Association for the Advancement of Medical Instrumentation’s (AAMI) guidelines state that no loaded tray should be heavier than 25 pounds, including the weight of the tray itself.2 With all instruments, implants, trays, graphic case and lid, the Core Set weight is 22 pounds (10 kilograms) – Auxiliary Tray may be used to hold additional instruments not configured in tray.

Reduction Instruments Tray

2. “Heavy Instrument Sets Shed Pounds,” OR Manager. February 2008. Accessed at https://www.ormanager.com/wp-content/uploads/pdfx/ORMVol24No2instrumentSetsShedPounds.pdf. 118841-190717 DSUS 8/19

Core Set supports USF Anatomic Implant Trays

Note: The USF Core Set can also be used with any DePuy Synthes 2.7mm or 3.5mm non-locking, LCP® or VA LCP® Implant System. Note for OR Staff: Surgeon preference cards may need to be changed based on what hospital used prior to Universal Small Fragment System. Note for OR Staff: Not all lengths and plate families offered are available in tray. Sterile packaged implants and screws may be needed in addition to the Core Set and Implant Tray

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USF Handle, Drivers, Bending Irons and Periosteal Elevator – Bending Irons: Combine function of F and Recon benders. Open and closed benders help secure the place while bending – Handle – fully cannulated. Ensure Cannulation is clean before using. Shaft snaps into collar automatically. Disassemble shaft from handle by pulling collar back – Driver Shafts: All drivers in system are self retaining. 2.5mm Hex driver will not retain low profile screws; use holding sleeve for low-profile cortex screws. Shaft must be disassembled from handle prior to cleaning and sterilization - Elevator: Do not strike the back of the elevator - Use cleaning stylet to ensure cannulation on devices are clear of debris before use

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Drill Guides Non-Locking Drill Guide

Variable Angle Drill Guide

Threaded Drill Guide

(Internal) Recess to allow StarDrive™ Screwdriver insertion

Notes ⁻ Spring loaded feature on Universal Drill guide removed in favor of using Neutral Sleeve adapter ⁻ Longer sleeve for soft tissue protection ⁻ Threaded drill guides may be used in VA LCP® or LCP® Screw Holes ⁻ VA Drill guides have freehand (tactile feedback) and VA Cone side ⁻ Color coordination with drill bits; single band for lagging, double band for gliding ⁻ Black = 3.5mm; Orange = 2.7mm ⁻ Direct measuring with calibrated drill bits; USF Drill bits calibrate with USF drill guides only. Cannot calibrate off of VA Cone 118841-190717 DSUS 8/19

Precautions ⁻ Neutral (i.e., centered) sleeve adaptors are not designed for use with LCP® Locking Holes or Variable Angle Locking Holes. They should be used only with non-threaded holes or the non-threaded portion of Combi holes ⁻ Avoid excessive angulation when using the Neutral Sleeve Adapter in the non-threaded holes and stay nominal to the central axis of the hole ⁻ Use cleaning stylet to ensure cannulation on devices are clear of debris before use

Drill Bits Part Number

Diameter

No. of Bands

Color Band

Function (Drill / Gliding)

03.133.100

2.0

1

Orange

Drill

03.133.101

2.0

1

Orange

Drill

03.133.102

2.5

1

Black

Drill

03.133.103

2.5

1

Black

Drill

03.133.104

2.5

1

Black

Drill

03.133.105

2.7

2

Orange

Gliding

03.133.106

2.8

1

Black

Drill

03.133.107

2.8

1

Black

Drill

03.133.108

2.8

1

Black

Drill

03.133.109

3.5

2

Black

Gliding

03.133.110

3.5

2

Black

Gliding

Note: Non-USF drill bits may be used with USF Drill Guides, but cannot calibrate with USF Drill guides 118841-190717 DSUS 8/19

03.133.101

Depth Gauge Assembly 1) Insert the measuring insert through the sleeve. Match the depth gauge key to the top of the depth gauge sleeve D-shape and gently advance towards the measuring insert handle until it stops. 2) Rotate 180 degrees in one direction while gently advancing toward the handle until a stop is felt. 3) Turn another 180 degrees in the opposite direction with gentle pressure applied on the sleeve towards the handle. 4) Advance the remainder of the insert down the depth gauge sleeve until the sleeve meets the depth gauge handle.

Please practice assembly and disassembly prior to use in OR. During assembly and disassembly, use care in carefully pushing in depth gauge measuring insert hook tip. Hook tip may be sharp and may pinch or tear user’s glove or skin. Maximum measurement for the 2.7/3.5 mm Depth Gauge 0 to 60 mm (03.133.080) is 66 mm; Maximum measurement for the 2.7/3.5 mm Depth Gauge 40 to 100 mm (03.133.081) is 106 mm. When measuring for 2.7 mm locking or variable angle locking screws, subtract 2 mm from the reading from the Depth Gauge. No subtraction is required for 3.5 mm screws and 2.7 mm nonlocking screws. Use cleaning stylet to ensure cannulation on devices are clear of debris before use. 118841-190717 DSUS 8/19

Disassembly 1) Advance the sleeve away from the handle until it stops at the hook tip. Push in hook tip to slide sleeve over the hook. The sleeve will stop at the key feature. 2) Navigate around key feature as described in assemble to complete disassembly.

Depth Gauge Tip

Depth Gauge Tip

3.5mm Locking

3.5mm VA Locking

2.7mm Non-Locking

Depth Gauge Tip

Depth Gauge Tip

3.5mm Non-Locking

Depth Gauge Tip

Depth Gauge Tip

Why do I have to subtract 2mm for measuring 2.7mm Locking and VA Locking Screws?

2mm

2.7mm Locking

2.7mm VA Locking

Simulation showing depth gauge tip resting into screw holes. Tip rests closer to middle of plate for all screw holes except 2.7mm Locking and VA LCP Locking. Tip rests approximately 2mm higher for these screw holes. Note: For illustration purposes only; not drawn to scale

• • • •

2.7mm LCP® and VA LCP® Holes have a smaller hole and more narrow geometry than the 2.7mm cortex or any of the 3.5mm screw holes. The geometry of the Depth Gauge tip allows the device to sit closer to the top of the 2.7mm Locking and VA Locking holes, while the tip can be inserted farther into the plate for the other screw holes. Consequently, the depth gauge wire measures from a slightly higher place on the plate for 2.7mm Locking and VA Locking holes. Subtracting 2mm for 2.7mm Locking and VA Locking is required to correct the longer measurement to ensure accurate screw selection.

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Screw Reference Chart printed on Screw Rack Push Pins for “Locking, VA Locking, Cortex, Metaphyseal”

Look for Screw Type on Push Pins above screws in Screw Rack

Screw Reference Chart • Appears on side of Screw Rack • Use to help identify drill bit, torque limiter and driver shaft needed for each screw diameter

Use for 2.7mm screws 118841-190717 DSUS 8/19

Use for 3.5mm screws

Use for 4.0mm screws

2.5mm Hex Driver – when to use Holding Sleeve 2.5mm Hex Driver does NOT retain Low Profile Cortex Screws Use Holding Sleeve (314.06) to secure screw to driver shaft

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2.5mm Hex Driver retains Standard Cortex Screws e.g., 2.7mm Cortex, 3.5mm Low Profile Cortex Screws

3.5mm Cortex Screws, 4.0mm Cancellous

Measuring screw length using gauge on Screw Rack • • •

Measuring gauge appears on side of Screw Rack as a pop out feature. While measuring screw length – either with an individual screw or a screw retained on a driver, ensure that the tip of the screw is flat against the wall of the measuring gauge on the screw Rack. Measure length from flat surface (top) of screw head.

Lie screw flat on measuring gauge, with tip of screw against wall surface (screw is 50mm length).

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If screw retained on driver, ensure screw tip flat against wall surface (screw is 50mm length).

Additional Resources

Surgical Technique Guide (www.DePuysynthes.com/hcp/trauma)

System Catalog (www.DePuysynthes.com/hcp/trauma)

System Brochure and Evidence Infographic if useful in the discussion about system benefits: https://www.depuysynthes.com/hcp/trauma/products/qs/universal-small-fragment-system US Regulatory Memo is available upon request (internal access only). All new instruments have been determined by DePuy Synthes to be Class 1 devices and are exempt from the FDA pre-market submission process. Regulatory Memo indicates such and provides all product codes released for the first time with the Universal Small Fragment System. 118841-190717 DSUS 8/19

Inventory Control Forms (www.DePuysynthes.com/hcp/trauma)

FOR USE WITH STERILIZATION PROCESSING STAFF

118841-190717 DSUS 8/19

Introduction The Universal Small Fragment (USF) System is intended to be used for small bone trauma, including anatomy such as Shoulder, Clavicle, Elbow, Tibia and Fibula. The core set can support any DePuy Synthes 2.7mm or 3.5mm non-locking, LCP® or VA LCP® Implant System Training topics for USF • System Trays • Instruments

118841-190717 DSUS 8/19

Universal Small Fragment (USF) System System Trays

✓ Core Set ✓ Anatomic Implant Trays

118841-190717 DSUS 8/19

Instruments

✓ Drill Guides ✓ Depth Gauge ✓ Handle and Driver Shafts ✓ Bending Irons ✓ Periosteal Elevator

Core Set Graphic Case Standard Plate Tray

Auxiliary Tray

US Guidelines: The Association for the Advancement of Medical Instrumentation’s (AAMI) guidelines state that no loaded tray should be heavier than 25 pounds, including the weight of the tray itself.2 With all instruments, implants, trays, graphic case and lid, the Core Set weight is 22 pounds (10 kilograms)

Screw Rack

Insertion Instruments Tray

Reduction Instruments Tray

2. “Heavy Instrument Sets Shed Pounds,” OR Manager. February 2008. Accessed at https://www.ormanager.com/wp-content/uploads/pdfx/ORMVol24No2instrumentSetsShedPounds.pdf. 118841-190717 DSUS 8/19

Core Set + USF Anatomic Implant Trays

Upper Limb Anatomic Implant Trays are available in Stainless Steel or Titanium LCP® Lower Limb Anatomic Implant Trays are available in Stainless Steel or Titanium VA LCP® Lower Limb Anatomic Implant Trays are available in Stainless Steel only

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