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	03/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 3/5/2024, it was reported by a sales representative via (b)(4) that (2) ar-8741-40 driver and (2) ar-8741-40s driver broke during use with no pieces breaking off inside the patient reported.The case was completed successfully, and no further information was provided.This was discovered during a metacarpal fx procedure on (b)(6) 2024, with no reported patient harm.Additional information was received on 3/7/2024: the drivers broke as the surgeon was attempting to get the final fixation for a metacarpal fracture.One of the drivers broke in the patient, taking 15 minutes to retrieve it.The other three drivers only cracked.All fragments were removed from the patient.A fourth driver was used to complete the procedure.They removed the screw, drilled again (cycling the drill), and then put the screw back in.The driver didn¿t crack, but the threads were damaged.Additional information was received on 3/8/2024: per the sales rep on photo attachment "one of the ar-8741-40s¿ broke in patient whole surgeon was advancing the screw and surgeon had to fish fragments out.The other short driver broke but did not fully disconnect from the driver.Same for the one long driver.The fourth drives threads were damaged.Please see picture attached.".
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint is confirmed.Upon visual inspection, it was noted that the drive geometry at the distal tip of the returned 3.5 mm beveled ft driver, cannulated, short, t10 hexalobe had broken off.Functional testing was not performed due to the damaged distal tip of the device.The most likely cause for the reported failure can be attributed to user error of the device due to over-torquing/over-engaging the inserter within the screw during use.

• 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: 18905261
• Report Number: 1220246-2024-01472
• Device Sequence Number: 9135683
• Product Code: LXH
• UDI-Device Identifier: 00888867362642
• UDI-Public: 00888867362642
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 12/05/2024

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: 1392236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2022
• 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