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	01/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Sales rep reported on (b)(6)2025 that the dvtx-8/110 ao np tip snapped off inside head of distal tpeg.It was reported that the device was not being used under power as the surgeon was using the hndl-quick by hand, the broken tip was not able to be removed and the surgeon reported the screw was adequately locked and opted to leave implant with screwdriver tip insitu.The surgeon reported no time delay, however, believed there is potential patient impact if the most distal screw with broken screwdriver tip requires revision.A picture was provided, no x-rays were provided but the remainder of the device is available to be returned.

• 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; santa clarita CA 91355
• Manufacturer (Section G): TRIMED, INC.; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer Contact: megan rissler ; 27533 avenue hopkins; santa clarita, CA 91355
• MDR Report Key: 21375889
• Report Number: 2031009-2025-00002
• Device Sequence Number: 15568201
• Product Code: HXX
• UDI-Device Identifier: 00842188126055
• UDI-Public: 00842188126055
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2025

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
• Device Catalogue Number: DVTX-8/110 AO NP
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2025
• 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