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	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A sales rep reported on (b)(6) 2025 that when the surgeon was inserting the second tpeg into the volar distal row, he was instructed to just snug the tpeg and the tip of the dvtx-8 np broke off.It was reported that there was no delay in surgery because the surgeon was instructed to move on and insert the additional screws needed to fixate the fracture.The surgeon then went back after all screws were implanted to try to remove the driver tip, with no success.The tip remains insitu and the surgeon believes no additional harm is expected because the tip of the driver is flush with the screw head.While the device is not intended to come in contact with the patient, the tip of the device remains implanted inside of the screw head.

• 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
• MDR Report Key: 22688397
• Report Number: 2031009-2025-00019
• Device Sequence Number: 6166239
• 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): 08/01/2025

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: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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