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

Model Number	3-POINT SHOULDER DISTRACTION SYSTEM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem 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.
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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.Based on the image provided from the field, it is evident that that the wire broke.Consequently, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to wear and tear.

• 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: jared engle ; 8009337001
• MDR Report Key: 18994716
• Report Number: 1220246-2024-01685
• Device Sequence Number: 2997585
• Product Code: HST
• UDI-Device Identifier: 00888867019911
• UDI-Public: 00888867019911
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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