MAUDE Adverse Event Report: TRIMED VOLAR BEARING PLATES; VOLAR BEARING PLATE, 3-HOLE, LT, NARROW

Model Number	VBEAL-3-7N
Medical Device Problem Codes	Off-Label Use (1494); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Trimed's medical advisor reported on 05nov2023 that a surgeon informed him that on one case, he was using a wrist fixation system 3 volar bearing plate and used a standard bone screw to pull the plate up to the bone.This is not on the trimed surgical technique manual, therefore this was off label use.When the surgeon went to put the peg in, he thinks that the bearing may have come out of the bottom of the plate, but felt that fixation was excellent, was pleased with the result, and didn't feel removal was needed or necessary.It has been reported that the patient has done great and this did not cause additional harm.

• Brand Name: VOLAR BEARING PLATES
• Common Device Name: VOLAR BEARING PLATE, 3-HOLE, LT, NARROW
• Manufacturer (Section D): TRIMED; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer (Section G): TRIMED; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer Contact: megan rissler ; 27533 avenue hopkins; santa clarita, CA 91355
• MDR Report Key: 18223020
• Report Number: 2031009-2023-00007
• Device Sequence Number: 5709719
• Product Code: HRS
• UDI-Device Identifier: 00842188124907
• UDI-Public: 00842188124907
• 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
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/28/2023

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: VBEAL-3-7N
• Device Catalogue Number: VBEAL-3-7N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2031009-11/28/2023-001-R
• Patient Sequence Number: 1
• Patient Sex: Unknown