MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PERCUTANEOUS RADIOLUCENT INSERTION HANDLE; ROD,FIXATION,INTRAMEDULLARY

Model Number	03.037.112
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	05/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2020, the surgeon inserted a proximal femoral nailing system (tfna) nail using the percutaneous radiolucent handle.After the nail was inserted, lag screw inserted, and distal locking screw inserted, the surgeon attempted to remove the handle using the t-handle ball hex 8 mm screwdriver.The end of the screwdriver broke off at the top of the connecting screw.After attempting to remove the broken end of the screwdriver, it was determined that it could not be removed which prohibited the handle from being removed from the nail.The surgeon determined that the best course of action would be to cut the percutaneous radiolucent handle close to the connection to the nail to gain better access and potentially be able to remove the screwdriver tip that broke off in the connecting screw.The hope was that if the broken piece could be removed then the handle could be removed.After cutting the handle it was determined that the piece could still not be removed and that the end of the handle, broken screwdriver piece and connecting screw would have to be left in the patient.Action taken when the event occurred multiple options were explored and considered.Three (3) pieces of different instruments had to be left.Tip of t-handle ball hex 8 mm screwdriver, the metal part of percutaneous radiolucent insertion handle that connects to the nail, and the connecting screw.Another medical intervention was required there are many additional intra-operative xrays needed to attempt to remove the instruments from the implant.There was a surgical delay of one hundred twenty (120) minutes.The procedure was not successfully completed.There was a patient consequence the surgery occurred today, so it is too early to determine inflammation or infection.However, three instrument pieces not intended to be implanted had to be left because the screwdriver broke off.Concomitant devices reported: unknown nails: tfna (part# unknown, lot# unknown, quantity# 1).Unknown nail head elem: tfna lag screw (part# unknown, lot# unknown, quantity# unknown).Unknown screws: locking (part# unknown, lot# unknown, quantity# unknown).This complaint involves three (3) devices.This is report 2 of 3 for (b)(4).

• Brand Name: PERCUTANEOUS RADIOLUCENT INSERTION HANDLE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10120280
• Report Number: 2939274-2020-02664
• Device Sequence Number: 19371483
• Product Code: HSB
• UDI-Device Identifier: 10886982070562
• UDI-Public: (01)10886982070562
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.037.112
• Device Catalogue Number: 03.037.112
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2020
• Initial Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CANNULATED CONNECTING SCREW; T-HANDLE BALL HEX SCREWDRIVER 8 MM; UNK - NAIL HEAD ELEM: TFNA LAG SCREW; UNK - NAILS: TFNA; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Weight: 181