MAUDE Adverse Event Report: TRIMED, INC. VOLAR BEARING PLATE, 3-HOLE, RT

Model Number	VBEAR-3-7S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A sales rep reported on 10jun2025 that a surgeon had two ws3 volar bearing plate failures where he indicated he thought the bearing wasn't locking into the plate properly.A sales rep provided additional information on 25jun2025 with x-rays for both cases and the devices were identified as the vbear-3-7s and vbear-5-7s.The surgeon reported that there were no post-op injuries and no associated co-morbidities.Revision surgery was after 3 months for the 1st patient, vbear-3-7s (exact implant date and removal date unk) and 4 months after for the second patient vbear-5-7s (exact implant date and removal date unk).It was observed through x-ray photos provided that the proximal row of the plate did not have any screws implanted.The surgeon stated that during the initial surgery the bearings were locked at the end of both cases.Finally, it was reported that the 1st patient had additional surgery to remove the plate and the 2nd patient ruptured her fpl tendon which will require reconstruction of the tendon.

• Brand Name: VOLAR BEARING PLATE, 3-HOLE, RT
• Common Device Name: VOLAR BEARING PLATE, 3-HOLE, RT
• 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: 22438757
• Report Number: 2031009-2025-00015
• Device Sequence Number: 3201226
• Product Code: HRS
• UDI-Device Identifier: 00842188125027
• UDI-Public: 00842188125027
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K222637
• 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): 07/08/2025

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: VBEAR-3-7S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2025
• 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: Required Intervention
• Patient Sex: Unknown