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

Model Number	DVTX-8 NP
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A sales rep reported on 28apr2025 that the dvtx-8/110 ao np and dvtx-8 np tips twisted during insertion of tpeg screws.Additional pictures were provided on 12may2025 showing the tips broke.The rep confirmed on (b)(6) 2025 that the broken tips remain in the implanted screws and the surgeon was not concerned with adverse effect to patient.While they tried several ways to remove the tip, the surgeon couldn't so felt safe leaving them insitu.A picture was provided however both drivers have been discarded.

• Brand Name: TORX 8 DRIVER, NIPPLE TIP
• Common Device Name: TORX 8 DRIVER, 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; valencia, CA 91355
• MDR Report Key: 22073989
• Report Number: 2031009-2025-00005
• Device Sequence Number: 9394175
• Product Code: HXX
• UDI-Device Identifier: 00842188126048
• UDI-Public: 00842188126048
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2025

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 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: 05/22/2025
• 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