MAUDE Adverse Event Report: ARTHREX, INC. DRIVER, T10 HEXALOBE, SHORT, BEVELED FT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DRIVER, T10 HEXALOBE, SHORT, BEVELED FT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2023
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.Event description: it was reported that during a minimally invasive foot surgery the device broke before the insertion in the patient.4mm of the screwdriver tip broke off.The reported event was confirmed as the evaluation revealed that the drive geometry at the distal tip had broken off (see evaluation picture 3).No fragments were returned for inspection.The most likely cause for the reported failure can be attributed to user-applied excessive mechanical forces.
Event or Problem Description
It was reported that during a minimally invasive foot surgery the device broke before the insertion in the patient.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.Update 17-jan-2023 nen: further information revealed that 4mm of the screwdriver tip broke off.The broken pieces were retrieved from patient.

• Brand Name: DRIVER, T10 HEXALOBE, SHORT, BEVELED FT
• 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: 19472929
• Report Number: 1220246-2024-05009
• Device Sequence Number: 17870959
• Product Code: LXH
• UDI-Device Identifier: 00888867362642
• UDI-Public: 00888867362642
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/05/2024

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: DRIVER, T10 HEXALOBE, SHORT, BEVELED FT
• Device Catalogue Number: AR-8741-40S
• Device Lot Number: 1392132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• 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