MAUDE Adverse Event Report: TRIMED, INC. TORX 8 DRIVER, 110MM NIPPLE TIP

Model Number	DVTX-8/110 AO NP
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Sales rep reported on (b)(6) 2025 that in a distal radius case with a surgeon, they had a dvtx-8/110 ao np break.It was reported that this occurred at the end of the case so it didn't change the outcome of the surgery.The rep confirmed the remaining piece of the broken tip was left in the head of the screw as it could not be removed so it remains implanted.This caused less than a 5-minute delay in surgery and potential patient harm is unknown.The device was discarded at the facility.

• Brand Name: TORX 8 DRIVER, 110MM NIPPLE TIP
• Common Device Name: TORX 8 DRIVER, 110MM NIPPLE TIP
• Manufacturer (Section D): TRIMED, INC.; 27533 avenue hopkins; valencia CA 91355
• Manufacturer (Section G): TRIMED INC; 27533 avenue hopkins; valencia CA 91355
• Manufacturer Contact: megan rissler ; 27533 avenue hopkins; valencia 91355
• MDR Report Key: 22819471
• Report Number: 2031009-2025-00021
• Device Sequence Number: 5738670
• Product Code: HXX
• UDI-Device Identifier: 00842188126055
• UDI-Public: 00842188126055
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2025

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: DVTX-8/110 AO NP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown