MAUDE Adverse Event Report: TRIMED, INC. 1ST MTP 0 DEGREE DORSIFLEXED,RT,7-HOLE

Model Number	MTPR-7
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Sales rep reported on (b)(6) 2026 that during a routine post-op appointment, a surgeon found a broken mtpr-7 through x-rays.It was reported that the patient is not experiencing any pain so the surgeon has opted to leave the device insitu and plans to see the patient back in 6 months.As of (b)(6) 2026 it is unknown if leaving the device implanted will cause the patient any additional harm, there is no patient information and there is no knowledge if the patient has followed all post-op instructions.As of (b)(6) 2026 the device remains implanted.

• Brand Name: 1ST MTP 0 DEGREE DORSIFLEXED,RT,7-HOLE
• Common Device Name: 1ST MTP 0 DEGREE DORSIFLEXED,RT,7-HOLE
• 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: 24509772
• Report Number: 2031009-2026-00002
• Device Sequence Number: 21460189
• Product Code: HRS
• UDI-Device Identifier: 00842188120015
• UDI-Public: 00842188120015
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K192696
• 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): 03/04/2026

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: MTPR-7
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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