MAUDE Adverse Event Report: TRIMED, INC. WIRE CUTTER, 1.1MM

Model Number	CUTRWIR-1.1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Oversedation (1990)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A sales rep reported on 10jun2025 that cutrwir-1.1 from the trimed wrist fixation system broke during surgery.Surgeon reported this issue caused a 40 minute delay until they found a replacement.Given this system is used only once a month, this issue was not due to heavy usage.It was confirmed that the device did not come into contact with the patient and no broken parts of the device were left in the patient.

• Brand Name: WIRE CUTTER, 1.1MM
• Common Device Name: WIRE CUTTER, 1.1MM
• Manufacturer (Section D): TRIMED, INC.; 27533 avenue hopkins; valencia CA 91355
• Manufacturer (Section G): TRIMED, INC.; 27533 avenue hopkins; valencia CA
• Manufacturer Contact: megan rissler ; 27533 avenue hopkins; valencia, CA 91355
• MDR Report Key: 22438775
• Report Number: 2031009-2025-00018
• Device Sequence Number: 11920166
• Product Code: HXZ
• UDI-Device Identifier: 00842188113697
• UDI-Public: 00842188113697
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CUTRWIR-1.1
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown