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

Model Number	OSTEOTOMY DISTRACTOR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
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
It was reported that during a lower ankle joint arthrodesis surgery the device ar-13225 (lot: 6672108) was used and was hard to rotate and ultimately broke.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully without the device.It was not necessary to switch the surgical technique or do a second surgery.
Event or Problem Description
Update avoe 17-sep-2024: it was confirmed that the device broke outside of the patient, and nothing had to be retrieved from the patient.
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 a most likely cause.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.

• Brand Name: OSTEOTOMY 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: 20146502
• Report Number: 1220246-2024-07381
• Device Sequence Number: 8301843
• Product Code: LXH
• UDI-Device Identifier: 00888867010109
• UDI-Public: 00888867010109
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup,Followup
• Report Date (Section B): 06/24/2025

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: OSTEOTOMY DISTRACTOR
• Device Catalogue Number: AR-13225
• Device Lot Number: 6672108
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: Not provided; 06/09/2025
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 09/26/2024; 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2021
• 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