MAUDE Adverse Event Report: TRIMED, INC. SAW GUIDE A, 2MM

Model Number	UOSG-A-2
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Sales rep reported on 23sep2025 that while covering a (b)(6) case with a surgeon and a (b)(6) resident (leading), they encountered an issue with the 2mm a cut guide.It was stated that following some difficulty making the initial cut, the surgeon noticed that the a cut guide was slightly bent.It was unclear if it might have been slightly bent initially or if something during the case caused the guide to bend.Regardless, they decided to revise after making the b cut resulting in a larger wedge than planned.It was stated that the device came in contact with the patient per planned procedure however this caused over a 20-minute delay in surgery due to the repeated cut revision.The rep provided additional information on (b)(6) 2025 that permanent damage/impairment is unclear due to possible negative ulnar variance sequelae.He stated that he assumes the osteotomy will heal due to adequate compression (unclear if there may be subsequent symptoms/iatrogenic radiocarpal overload), however there was no mention of possible further intervention.The surgeon did not mention any suspected need for further intervention following the case and he did not appear particularly pleased with the enlarged wedge but was satisfied enough with the result.

• Brand Name: SAW GUIDE A, 2MM
• Common Device Name: SAW GUIDE A, 2MM
• 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: 23362511
• Report Number: 2031009-2025-00025
• Device Sequence Number: 9202453
• Product Code: LXH
• UDI-Device Identifier: 00842188112256
• UDI-Public: 00842188112256
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 10/22/2025

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: UOSG-A-2
• 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: 10/22/2025
• 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