MAUDE Adverse Event Report: ARTHREX, INC. MINI JOINT DISTRACTOR; TRACTION APPARATUS

Model Number	MINI JOINT DISTRACTOR
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 04/02/2025, a sales representative reported via (b)(6) that an ar-8950jd mini joint distractor stopped working.This occurred in a case on (b)(6) 2025, when the ratcheting mechanism on the device stopped working.A different distractor was brought in to complete the case.No adverse reactions to the patient occurred.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 the most likely cause.The most likely cause for the reported failure can be attributed to wear and tear of the device.The complaint allegation was not confirmed as the device was not received for evaluation, and no evidence of the failure was provided.

• Brand Name: MINI JOINT DISTRACTOR
• 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: 21865274
• Report Number: 1220246-2025-01554
• Device Sequence Number: 17323701
• Product Code: HST
• UDI-Device Identifier: 00888867054745
• UDI-Public: (01)00888867054745(10)121230
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 09/26/2025

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: MINI JOINT DISTRACTOR
• Device Catalogue Number: AR-8950JD
• Device Lot Number: 121230
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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