MAUDE Adverse Event Report: ARTHREX, INC. DRV SFT,CANN,QC,T15 HEXALOBE; MANUAL INSTR, GENERAL SURGICAL

Model Number	DRV SFT,CANN,QC,T15 HEXALOBE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
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 small surgery the screwdriver broke while inserting a screw.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.Update cmackenbach 15-may-2025: further information was received that all broken parts were retrieved from the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-8943-12, drive shaft, cannulated, qc, t15 hexalobe, serial/batch number (b)(6), was received for investigation.Upon visual inspection, it was noted that the hex tip had broken off.No fragments were returned for evaluation.No functional testing was performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user-applied excessive force during the tightening process.The complaint allegation is confirmed.Refer to investigation photos.
Event or Problem Description
Further information was received that a small surgery means an ankle surgery in this case.

• Brand Name: DRV SFT,CANN,QC,T15 HEXALOBE
• 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: 22074234
• Report Number: 1220246-2025-02167
• Device Sequence Number: 9374802
• Product Code: MDM
• UDI-Device Identifier: 00888867052222
• UDI-Public: (01)00888867052222(11)231116(10)1392344
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/01/2025

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: DRV SFT,CANN,QC,T15 HEXALOBE
• Device Catalogue Number: AR-8943-12
• Device Lot Number: 1392344
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2023
• 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