MAUDE Adverse Event Report: TRIMED, INC. OSTEOTOMY COMPRESSION CLAMP

Model Number	COMPC-UOS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A sales rep reported on (b)(6) 2025 that during a case the compc-uos was not compressing as intended due to the tool being worn.It was reported that this caused a 30-minute delay in surgery, the device did come in contact with the patient per planned procedure but no negative impact on patient was reported.

• Brand Name: OSTEOTOMY COMPRESSION CLAMP
• Common Device Name: OSTEOTOMY COMPRESSION CLAMP
• 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 91355
• MDR Report Key: 22159225
• Report Number: 2031009-2025-00013
• Device Sequence Number: 7273733
• Product Code: LXH
• UDI-Device Identifier: 00842188112232
• UDI-Public: 00842188112232
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2025

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: COMPC-UOS
• 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: 06/06/2025
• 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
• Patient Sex: Unknown