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	04/07/2021
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.Complaint confirmed, the threaded shaft broke.The threaded shaft was measured and found to meet dimensional specifications.The most likely cause for the reported failure can be attributed to wear and tear.
Event or Problem Description
It was reported that during a lapidus surgery the threaded part broke when the surgeon had opened the device.It was further reported that nothing broke off and the procedure was finished successfully with another device.There was no harm for patient, operator or third party reported.It was not necessary to switch the surgical technique or do a second surgery.

• 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: 19568138
• Report Number: 1220246-2024-06152
• Device Sequence Number: 6954773
• Product Code: HST
• UDI-Device Identifier: 00888867054745
• UDI-Public: 00888867054745
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/19/2024

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
• Device Catalogue Number: AR-8950JD
• Device Lot Number: 051845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown