MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T7 HEXALOBE CANNULATED; MANUAL INSTR, GENERAL SURGICAL

Model Number	DRIVER SHAFT, T7 HEXALOBE CANNULATED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
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 chevronette surgery the screwdriver broke at the tip.All parts could be completely removed.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-8610d-25 driver shaft, t7 hexalobe cannulated serial/batch (b)(6) was received for investigation.Visual evaluation revealed that the cannulated hex tip was broken off.Functional testing found was not performed due to the damaged of the device.The reported condition is most likely caused by overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging.Device manufacturing date aug-20-2019.

• Brand Name: DRIVER SHAFT, T7 HEXALOBE CANNULATED
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 20639555
• Report Number: 1220246-2024-08470
• Device Sequence Number: 7432257
• Product Code: LXH
• UDI-Device Identifier: 00888867197268
• UDI-Public: (01)00888867197268(11)190830(10)60451927
• 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,Company Representative
• 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: DRIVER SHAFT, T7 HEXALOBE CANNULATED
• Device Catalogue Number: AR-8610D-25
• Device Lot Number: 60451927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2019
• 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