MAUDE Adverse Event Report: ARTHREX, INC. WRIST TRACTION TOWER; TRACTION APPARATUS

Model Number	WRIST TRACTION TOWER
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cable of the wrist traction tower needs to be replaced.There was no harm for patient, operator or third party reported.No further information received.
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.Event description: it was reported that the cable of the wrist traction tower needs to be replaced.The reported event was confirmed.The manufacturer evaluation revealed the tower is completely damaged and beyond any repair.Considering the age of the device (mfg 2015), the most likely cause is attributed to wear and tear.

• Brand Name: WRIST TRACTION TOWER
• 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: 19400607
• Report Number: 1220246-2024-03989
• Device Sequence Number: 8364888
• Product Code: HST
• UDI-Device Identifier: 00888867020061
• UDI-Public: 00888867020061
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/27/2024

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: WRIST TRACTION TOWER
• Device Catalogue Number: AR-1611S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 05/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2015
• 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