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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.  arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The reported event is confirmed.The manufacturers evaluation revealed that the rope is defective which caused the reported event.The most likely cause for the reported failure can be attributed to misuse due to user error of the device due to excessive force being applied during use.
Event or Problem Description
It was reported that the wire rope snapped at the middle bar.There was no harm or adverse event for patient, operator or third party reported.No further information received.

• 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: 19397069
• Report Number: 1220246-2024-03905
• Device Sequence Number: 15376036
• Product Code: HST
• UDI-Device Identifier: 00888867019911
• UDI-Public: 00888867019911
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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