MAUDE Adverse Event Report: TriMed, Inc. Volar Bearing Plate, 3-Hole, Lt

Catalog Number	VBEAL-3-7S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Sales rep reported on (b)(6) 2026 that a when a surgeon was implanting a vbeal-3-7, a tpeg2.4 screw passed through the plate.The surgeon had to remove the already implanted screws and plate to switch to a new vbeal-3-7s to complete the surgery which took approx.30 minutes.The second plate was implanted successfully with no further issues.The rep was not present during the case but after they spoke to the r4, he believed the bearing was disrupted when they drilled using the single sided tissue protector.After trimed product management spoked with the rep, the rep is unsure if the bearing popped out and did not know which screw hole was affected.Another sales rep stated on (b)(6) 2026 that the surgeon did not use the term that the bearing popped out but when they advanced the screw the screw basically broke through the bearing using the tpeg 2.4.

• Brand Name: Volar Bearing Plate, 3-Hole, Lt
• Common Device Name: Volar Bearing Plate, 3-Hole, Lt
• 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: 50696722
• Report Number: 2031009-2026-00013
• Device Sequence Number: 12235065
• Product Code: HRS
• UDI-Device Identifier: 00842188124938
• UDI-Public: 00842188124938
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K222637
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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 Catalogue Number: VBEAL-3-7S
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 09/09/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown