MAUDE Adverse Event Report: ARTHREX, INC.; BONE FIXATION PLATE

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Insufficient Information (4580)

Event Date 10/23/2023

Event Type  Injury  

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.

Event Description

On 16th november 2023, the copenhagen university hospital hvidovre, department of orthopedics provided the final report of their clinical study.The study indicating that over the last 2 years in total 400 patients were treated with the arthrex ankle fracture management system and during the period 37 adverse events have occurred.16 out of these 37 adverse events resulted in a revision surgery.The revision was necessary after 145 days due to loosening of the tightrope.No further information was provided.

• Brand Name: UNK
• Type of Device: BONE FIXATION PLATE
• 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: 18337037
• MDR Text Key: 330616879
• Report Number: 1220246-2023-09396
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/15/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/15/2023
• 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