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

Model Number	MINI JOINT DISTRACTOR/COMPRESSOR
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
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 complaint is not confirmed.One unpackaged ar-8970jd was received for investigation.Functional testing identified that all movable components were able to be manipulated.The knob and arm rack components functioned as intended.No problem found.
Event or Problem Description
It was reported that during a surgery there were two problems.The screw driver for 4,5 mm screws with the golden tip didn´t fit in the cortical screw ar-8545-xx properly.And the mini joints distractor ar-8970jd jammed and only could extract, but not compress.

• 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: 19261482
• Report Number: 1220246-2024-02906
• Device Sequence Number: 2569088
• Product Code: HST
• UDI-Device Identifier: 00888867307377
• UDI-Public: 00888867307377
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2024

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: MINI JOINT DISTRACTOR/COMPRESSOR
• Device Catalogue Number: AR-8970JD
• Device Lot Number: 6402180809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2019
• 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