MAUDE Adverse Event Report: ARTHREX, INC. 3-POINT SHOULDER DISTRACTION SYSTEM; TRACTION APPARATUS

Model Number 3-POINT SHOULDER DISTRACTION SYSTEM

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/11/2024

Event Type  malfunction  

Event Description

On (b)(6) 2024, it was reported by a sales rep.Via email that for an ar-1600m, 3-point shoulder distraction system, the lateral shoulder traction unit broke as the wire had snapped.This was detected during use in a shoulder arthroscopic stabilization procedure on (b)(6) 2024.The procedure was completed successfully with a spare traction unit at the hospital.

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: 3-POINT SHOULDER DISTRACTION SYSTEM
• Type of Device: TRACTION APPARATUS
• 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: 18994716
• MDR Text Key: 338883153
• Report Number: 1220246-2024-01685
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 00888867019911
• UDI-Public: 00888867019911
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 3-POINT SHOULDER DISTRACTION SYSTEM
• Device Catalogue Number: AR-1600M
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/11/2024
• 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