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

Catalog Number	DVTX-8 NP
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Sales rep reported on (b)(6) 2025 that a dvtx-8 np broke during surgery.The surgeon stated that during the final tightening of the distal 2.4 mm locking pegs, the tip of the screwdriver broke off in the head of the screw.The tip of the driver had cold welded into the screw and the surgeon could not remove it so it remains implanted.Additional information was provided on 08jul2025 that this caused a 2-minute delay in surgery and the surgeon does not believe leaving the broken piece in the screw head will cause the patient additional harm.

• Brand Name: TORX 8 DRIVER, NIPPLE TIP
• Common Device Name: TORX 8 DRIVER, NIPPLE TIP
• Manufacturer (Section D): TRIMED, INC.; 27533 avenue hopkins; valencia
• Manufacturer (Section G): TRIMED, INC.; 27533 avenue hopkins; valencia
• Manufacturer Contact: megan rissler ; 27533 avenue hopkins; valencia, CA 91355
• MDR Report Key: 22438755
• Report Number: 2031009-2025-00017
• Device Sequence Number: 3201225
• Product Code: HXX
• UDI-Device Identifier: 00842188126048
• UDI-Public: 00842188126048
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

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 Catalogue Number: DVTX-8 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: 07/08/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown