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	Failure of Implant (1924)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
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 an ankle fracture repair the implant broke on insertion.A second incision had to be made to retrieve the broken implant.All was retrieved and no fragments remained in the patient.It was replaced with another ar-8973l-30-130 with a different lot number and the case was completed with no further issues.The patient is fine to date.

• 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: 11545926
• Report Number: 1220246-2021-02767
• Device Sequence Number: 11613593
• Product Code: HSB
• UDI-Device Identifier: 00888867295209
• UDI-Public: 00888867295209
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/22/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: 3.0X130MM FIBULA NAIL, LEFT
• Device Catalogue Number: AR-8973L-30-130
• Device Lot Number: 10605043
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1