MAUDE Adverse Event Report: ARTHREX, INC. 3.0X130MM FIBULA NAIL, LEFT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3.0X130MM FIBULA NAIL, LEFT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported during a primary percutaneous procedure that took place on (b)(6) 2019, the surgeon was attempting to put a sonoma 3.5 x 55 ((b)(4) / lot: a17111705 ) screw into the ar-8973l-30-130 fibula nail (lot: 10297815), but the screw would not line up and the surgeon could not get the right trajectory.The surgeon was able to achieve good fixation without using the screw.The fibula nail was left implanted, and the case was completed successfully.The patient came in for a follow up visit on (b)(6) 2019 and during the follow-up visit it was discovered that the patient ambulated on the nail post-operatively and re-fractured their fibula.A revision/removal procedure took place on (b)(6) 2019, and was performed by the same surgeon at the same facility.During the revision procedure, the ar-8973l-30-130 was successfully removed.Upon removal, it was discovered that the device is labeled as an ar-8973l-30-130 (left) nail, but the device is actually a right nail.The nail was reinserted on the jig, and upon further investigation all holes lined up as a right nail.It was also discovered that the lot number etched on the device is different than the lot number that was on the original packaging (lot: 10297815).The lot number physically etched on the device is lot: 10286779.The rep confirmed no other arthrex parts were implanted during the revision procedure, and the case was completed.The rep stated that the discrepancy with the lot numbers, and incorrect part were not discovered/noticed during the primary procedure.The rep confirmed all arthrex parts that were implanted during the primary procedure were removed during the revision.The rep confirmed only the ar-8973l-30-130 is available to return for evaluation.The explanted screws were discarded.The following arthrex parts were implanted during the primary procedure: ar-8973ds // lot: 10293742 // qty.1 (implant system used), ar-8973l-30-130 // lot: 10297815 // qty.1, ar-8827l-14 // lot: unknown // qty.1, ar-8827l-16 // lot: unknown // qty.1, ar-8827l-22 // lot: unknown // qty.1.Additional information received on (b)(6) 2019: the fibulock implant system (ar-8973ds) was used.This kit includes a 6.2 distal reamer, a 3.2 proximal reamer and the 2.0 drill bit for distal screw fixation.The sonoma ((b)(4)) 2.5 mm syndesmotic drill was also used to prepare the bone.The bone was of good quality (hard to medium) and no graft was utilized in the case.
Additional Manufacturer Narrative
Complaint confirmed.After evaluation it was confirmed that the device is a right nail instead of a left nail.However, the device has a universal curvature and also the surgeon confirmed good fixation as stated in the event description.Therefore, a most likely cause is patient non-compliance.

• Brand Name: 3.0X130MM FIBULA NAIL, LEFT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8739490
• Report Number: 1220246-2019-01181
• Device Sequence Number: 2637799
• Product Code: HSB
• UDI-Device Identifier: 00888867295209
• UDI-Public: 00888867295209
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2019

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?: No
• Operator of Device: No Information
• Device Expiration Date: 03/31/2024
• Device Model Number: 3.0X130MM FIBULA NAIL, LEFT
• Device Catalogue Number: AR-8973L-30-130
• Device Lot Number: 10297815
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other