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

Model Number	DVTX-8 NP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Sales rep reported on 30sep2024 that on (b)(6) 2024, a surgeon performed a distal radius orif using the ws3 system.When the surgeon was implanting the distal 2.4mm screws, the dvtx-8 np tip snapped off in the head of the screw and was not able to be retrieved.It was stated that the dvtx-8 np came in contact with the screw but not the patient.In addition, there is nothing to be seen on the x-ray with regard to this as the tip of the screwdriver snapped and was retained in the recess in the head of the screw.This caused about a 5-10 minute delay in surgery.The surgeon opted to leave the screw implanted in situ but the remainder of the driver is available to be returned.

• 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; santa clarita, CA 91355
• MDR Report Key: 20482538
• Report Number: 2031009-2024-00006
• Device Sequence Number: 4105471
• Product Code: HXX
• UDI-Device Identifier: 00842188126048
• UDI-Public: 00842188126048
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2024

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
• Device Catalogue Number: DVTX-8 NP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/18/2024
• 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