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

Model Number	3.0X130MM FIBULA NAIL, RIGHT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/23/2020
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, that during an ankle fracture repair procedure, during insertion of the ar-8972r-30-130 the proximal talons opened prior to deployment with the driver.The surgeon tried to tap with the impactor however, still a lot of resistance.The surgeon removed the ar-8972r-30-130, used the white handled driver to disengaged the talons, until they were flush with the shaft.The surgeon inserted the same ar-8972-30-130 and the same problem occurred.The ar-8972r-30-130 was logged and the talons broke off.The surgeon removed the ar-8972-30-130 unable to retrieve the broken talon.The surgeon used the same insertion site and completed the case using a different ar-8972r-30-130.

• Brand Name: 3.0X130MM FIBULA NAIL, RIGHT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11186228
• Report Number: 1220246-2021-02476
• Device Sequence Number: 729617
• Product Code: HSB
• UDI-Device Identifier: 00888867295216
• UDI-Public: 00888867295216
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K173656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/18/2021

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: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: 3.0X130MM FIBULA NAIL, RIGHT
• Device Catalogue Number: AR-8973R-30-130
• Device Lot Number: 11473940
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 01/18/2021
• 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