MAUDE Adverse Event Report: ARTHREX, INC. HINDFOOT NAIL CABLE TENSIONER; INTRAMED FIXATN ROD AND ACCESS

Model Number HINDFOOT NAIL CABLE TENSIONER

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/13/2024

Event Type  malfunction  

Event Description

On (b)(6) 2024, it was reported by a sales representative via sems (b)(4) that an ar-9091-02 hindfoot nail cable tensioner screw is stripped.It was hard to tighten and loosen.Was damaged when putting it on the jig.As soon as it was placed on the jig it popped off.This was discovered during a procedure with no patient harm.

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: HINDFOOT NAIL CABLE TENSIONER
• Type of Device: INTRAMED FIXATN ROD AND ACCESS
• 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: jared engle ; 8009337001
• MDR Report Key: 18997293
• MDR Text Key: 338882819
• Report Number: 1220246-2024-01710
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00888867335301
• UDI-Public: 00888867335301
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HINDFOOT NAIL CABLE TENSIONER
• Device Catalogue Number: AR-9091-02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1