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

Model Number VBEAL-3-7N

Device Problems Off-Label Use (1494); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2023

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 329576200
• Report Number: 2031009-2023-00007
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00842188124907
• UDI-Public: 00842188124907
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2031009-11/28/2023-001-R
• Patient Sequence Number: 1