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

Model Number	3-POINT SHOULDER DISTRACTION SYSTEM
Medical Device Problem Codes	Defective Device (2588); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.
Event or Problem Description
Additional information was provided on 12/13/2023 where the sales representative stated that this event occurred during a left shoulder arthroscopy on (b)(6)2023.They used tape to secure the weights.
Additional Manufacturer Narrative
Additional information was provided on 12/13/2023 where the sales representative stated that this event occurred during a left shoulder arthroscopy on (b)(6)2023.They used tape to secure the weights.

• Brand Name: 3-POINT SHOULDER DISTRACTION SYSTEM
• Common Device Name: 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
• Report Number: 1220246-2023-09646
• Device Sequence Number: 3968651
• Product Code: HST
• UDI-Device Identifier: 00888867019911
• UDI-Public: 00888867019911
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 11/28/2023; 12/13/2023
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 02/26/2024; 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown