MAUDE Adverse Event Report: TRIMED, INC. ULNAR OSTEOTOMY COMPRESSION PLATE

Model Number	UOCP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Musculoskeletal problem (4535)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Regional sales manager reported on (b)(6) 2026 that a surgeon encountered the plate 'lifting' from the bone after his over-compression and believes it may have led to over shortening.The surgeon mentioned the scrub tech believed the issue was doing a quarter turn loosening in this case might have been too much which allowed the compression to slide up under the plate and pulled the plate away a little bit which is allowing the over shortening.The surgeon agreed that this was the cause and said even when using the clamp, it would not necessarily prevent lift off proximately once its compressed stating he had very good apposition and no side-to-side translation.The surgeon is thinking loosening maybe only an eight of a turn will help alleviate the issue in future cases.The surgeon stated there was no hardware malfunction and no adverse patient affect in theory, however, with over shortening he won't know the effect until the patient is finished healing.

• Brand Name: ULNAR OSTEOTOMY COMPRESSION PLATE
• Common Device Name: ULNAR OSTEOTOMY COMPRESSION PLATE
• 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: 24987661
• Report Number: 2031009-2026-00005
• Device Sequence Number: 13186323
• Product Code: HRS
• UDI-Device Identifier: 00842188101526
• UDI-Public: 842188101526
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K043263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: UOCP
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/24/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown