MAUDE Adverse Event Report: ARTHREX, INC. MINI JOINT DISTRACTOR/COMPRESSOR; ORTHOPEDIC MANUAL SURG INSTR

Model Number	MINI JOINT DISTRACTOR/COMPRESSOR
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
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 01/06/2025, it was reported by a sales representative via (b)(4) that an ar-8970jd mini joint distractor/compressors switch to flip the distractor from compression-neutral-distraction positions, is difficult to engage.This occurred during a case and cause no harm on the patient.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Visual evaluation noted that the knob has an abrasion mark on the top of the three edges.The part has discoloration on the arm rack of the mini joint distractor/compressor.Functional testing was performed the knob was found that flipped easily and did not seat on the neutral position.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage in the field.Manufacturing date 2020.

• Brand Name: MINI JOINT DISTRACTOR/COMPRESSOR
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 21264012
• Report Number: 1220246-2025-00098
• Device Sequence Number: 4604146
• Product Code: HST
• UDI-Device Identifier: 00888867307377
• UDI-Public: (01)00888867307377(11)200302(10)6402180814
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 02/18/2025

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/COMPRESSOR
• Device Catalogue Number: AR-8970JD
• Device Lot Number: 6402180814
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2020
• 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