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	06/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a removal of metalwork the tip of the device broke while removing a 3.5 comp ft screw.All parts were retrieved from 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.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, it was noted that the distal drive geometry of the 3.5 mm beveled ft driver, cannulated, short, t10 hexalobe had broken off.Functional testing was not performed due to the damage to the device.It was not indicated if a torque-indicating adapter had been used with the device.The most likely cause is attributed to over-torquing/over-engaging the driver within the screw head.

• 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: 19748996
• Report Number: 1220246-2024-06758
• Device Sequence Number: 15672276
• Product Code: LXH
• UDI-Device Identifier: 00888867362642
• UDI-Public: 00888867362642
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/27/2024

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: 1392246
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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