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

Model Number 3-POINT SHOULDER DISTRACTION SYSTEM

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 11/28/2023

Event Type  malfunction  

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 11/28/2023, it was reported by a sales representative via (b)(4) that an ar-1600m 3-point shoulder distraction system looked like the crimp failed, the weights hit the ground and the patient's arm dropped onto the sterile field.This occurred during a case.There was no additional information provided and additional information has been requested.

Manufacturer Narrative

Additional information: h6.The complaint was confirmed.One unpackaged ar-1600m 3-point shoulder distraction system batch 15032122 was received for evaluation.Upon assembly and visual inspection of the device, it was noted that the shoulder suspension tower wire crimp was damaged.Also, it was noted that the red protector of the wire was broken.No functional test was performed due to the damage to the device.The reported condition is most likely caused by overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18395387
• MDR Text Key: 331676283
• Report Number: 1220246-2023-09646
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 00888867019911
• UDI-Public: 00888867019911
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• 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
• Device Lot Number: 15032122
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2022
• 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