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	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A sales rep reported on 22may2025, that the tip of the dvtx-8 np was over torqued and the tip twisted with the nipple coming off and remaining in the head of the implanted screw.It was reported that a second driver was used to implant the remaining screws and surgery was completed successfully.The surgeon reported no time delay, however, believed there is potential patient impact if the most distal screw with broken screwdriver tip may require revision.

• Brand Name: TORX 8 DRIVER, NIPPLE TIP
• Common Device Name: TORX 8 DRIVER, 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, CA 91355
• MDR Report Key: 22195908
• Report Number: 2031009-2025-00014
• Device Sequence Number: 9244274
• 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): 06/12/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown