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

Model Number	MINI JOINT DISTRACTOR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
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 10/11/2024, a sales representative via(b)(4) reported that an ar-8950jd mini joint distractor was broken, and no further information was provided.No adverse effects for the patient.This was discovered during a procedure, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-8950jd batch 121246 was received for investigation.Upon visual evaluation, it was noted that the device had significant signs of wear: fading laser marks and material degradation.Functional testing noted that the locking lever was loose.The most likely cause for the reported failure can be attributed to wear and tear.The manufacturing date is 2013.

• 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: 20524556
• Report Number: 1220246-2024-08243
• Device Sequence Number: 9044334
• Product Code: HST
• UDI-Device Identifier: 00888867054745
• UDI-Public: (01)00888867054745(10)121246
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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: 121246
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 02/04/2025
• 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