MAUDE Adverse Event Report: ARTHREX, INC. DRIVER, T8 HEXALOBE SELF RETAINING; MANUAL INSTR, GENERAL SURGICAL

Model Number	DRIVER, T8 HEXALOBE SELF RETAINING
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via sems-06641117 that an ar-8916-27 retaining driver tip is broken.This occurred during use in a case with no patient effect.
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.One unpackaged ar-8916-27, lot number 1392403, was received for investigation.Visual evaluation noted that the driver's tip was twisted and broken.Functional testing was not performed due to the damage to the device.It was not indicated if the device had been used with a torque-indicating adapter.The most likely cause for the reported failure can be attributed to over-torquing/over-engaging the driver with the screw head.

• Brand Name: DRIVER, T8 HEXALOBE SELF RETAINING
• 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: 20182136
• Report Number: 1220246-2024-07496
• Device Sequence Number: 18316811
• Product Code: MDM
• UDI-Device Identifier: 00888867177628
• UDI-Public: 00888867177628
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

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, T8 HEXALOBE SELF RETAINING
• Device Catalogue Number: AR-8916-27
• Device Lot Number: 1392403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2024
• 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