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

Model Number	3-POINT SHOULDER DISTRACTION SYSTEM
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 17 march 2025, it was reported by a sales representative via email that an ar-1600m 3-point shoulder distraction system was reported to have the cable being too long.The cable was wrapped around a post to make it shorter.This occurred on (b)(6) 2025 in stars during a shoulder labral repair.The case was completed successfully using the device with the cable wrapped around the post to shorten it.There was case involvement.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 complaint allegation is confirmed by the attached picture, which shows the cable wrapping the tube many times.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.

• 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: 21753811
• Report Number: 1220246-2025-01179
• Device Sequence Number: 8200071
• Product Code: HST
• UDI-Device Identifier: 00888867019911
• UDI-Public: (01)00888867019911(11)210712(10)13707213
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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
• Device Lot Number: 13707213
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown