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

Model Number	OSTEOTOMY DISTRACTOR
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a lower ankle joint arthrodesis surgery the device ar-13225 (lot: 672231) could no longer be opened after the sterilization process, because there was rust in the thread.Due to this rust the device could not be rotated more than half a turn.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.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
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 of the reported failure is attributed to misuse by the end user, specifically not following the instrument cleaning requirements and recommendations.The device was manufactured on november 23, 2022, and the failure occurred on (b)(6) 2024.The complaint allegation was not confirmed.The device was not received for evaluation, and no evidence of the failure was provided.

• 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: 20146713
• Report Number: 1220246-2024-07392
• Device Sequence Number: 8259038
• 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
• Report Date (Section B): 01/24/2025

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: 672231
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2022
• 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