MAUDE Adverse Event Report: ARTHREX, INC. 1.5MM HEX, CMP FT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	1.5MM HEX, CMP FT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was confirmed as the visual evaluation of the received ar-8737-37 with batch 1392408 noted that the distal end of the shaft was broken off (see evaluation pictures 3 + 4).The broken pieces were not returned for investigation.A functional test 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 of the reported failure is user error, which can be attributed to over-torquing/over-engaging the driver within the screw head.
Event or Problem Description
It was reported during the osteosynthesis of metacarpal fracture that the tip of the driver shaft broke off when the screw was being inserted.The tip of the driver shaft remained stuck in the screw, so the entire screw with the broken part was removed and a new screw was used in the same hole.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.

• Brand Name: 1.5MM HEX, CMP 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: 23726459
• Report Number: 1220246-2025-05435
• Device Sequence Number: 10691961
• Product Code: LXH
• UDI-Device Identifier: 00888867127159
• UDI-Public: (01)00888867127159(11)240308(10)1392408
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/05/2025

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: 1.5MM HEX, CMP FT
• Device Catalogue Number: AR-8737-37
• Device Lot Number: 1392408
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2024
• 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