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	06/25/2024
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
On 07/09/2024, a sales representative via sems- (b)(4) reported that (qty.2) of an ar-8741-40s 3.5 mm beveled ft driver broke during the case when trying to get a screw out, and the head of the driver broke off on both.The patient was not affected.This was discovered during a procedure, with no reported patient harm.Additional information was received on 7/15/2024: (qty.2) an ar-8741-40s 3.5 mm beveled ft driver broke inside the patient, and all fragments were retrieved.There was no case delay.There were no reported issues with the screw itself.This was discovered during a metacarpal fracture procedure on (b)(6) 2024.The case was completed using a solid t10 driver was used to back out the screw.A new hole was drilled, and a new screw was put in.The patient has not experienced adverse effects due to the issue.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-8741-40s serial/batch number (b)(6) was received for investigation.Upon visual inspection, it was determined that the hex tip had broken off.No functional testing was performed as the driver was received broken.The most likely cause will be misuse of excessive torque force.

• 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: 19793774
• Report Number: 1220246-2024-06845
• Device Sequence Number: 4197571
• Product Code: LXH
• UDI-Device Identifier: 00888867362642
• UDI-Public: 00888867362642
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/12/2024

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: 1392407
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2024
• 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