MAUDE Adverse Event Report: TRIMED INC VOLAR PEG THREADED

Device Problem Insufficient Information (3190)

Patient Problem Implant Pain (4561)

Event Date 04/07/2021

Event Type  Injury  

Event Description

A trimed sales rep reported on 22 apr 2021 that a removal surgery on (b)(6) 2021 had to be performed on a patient that has had the devices implanted for 17 years.The removal was prompted because the patient began feeling discomfort in the wrist joint.During the removal it was determined that the two screws causing the joint discomfort were stripped and unable to be removed.The surgeon tried removing the screws with trimed's removal kit as well as 2 other companies removal kits with no success.The devices remained implanted and will continue to monitor the patient.

• Brand Name: VOLAR PEG THREADED
• Type of Device: VOLAR PEG THREADED
• 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: stephanie rissler ; 27533 avenue hopkins; santa clarita, CA 91355 ; 6612557406
• MDR Report Key: 11784420
• MDR Text Key: 249287473
• Report Number: 2031009-2021-00003
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention