MAUDE Adverse Event Report: ARTHREX, INC.; BIO SOFT TISSUE FIXATN FASTNR

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Osteolysis (2377)

Event Date 10/27/2023

Event Type  Injury  

Event Description

It was reported that patient had an ankle joint surgery five years ago.It was noted that the patient has a distal fibula with osteolyses.Update swit 30-oct-2023: the initial surgery was just five years ago, with chronic atfl insufficiency.It was re-fixed by means of internalbrace.The doctor would now like to consider operating on the patient in a two-sided procedure.Fill up osteolysis and after 6 months do a tendon transfer.Further information has been requested.

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.If the device becomes available for evaluation, a follow-up report will be submitted.

• Brand Name: UNK
• Type of Device: BIO SOFT TISSUE FIXATN FASTNR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 18192238
• MDR Text Key: 328807326
• Report Number: 1220246-2023-08880
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other