MAUDE Adverse Event Report: TRIMED ULNAR PEG PLATE, 7-HOLE

Model Number UPG-7

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Non-union Bone Fracture (2369)

Event Date 01/16/2023

Event Type  Injury  

Event Description

Reporter (b)(6) reported on (b)(6) 2023 that upg-7 plate broke one month after being implanted.The plate was implanted on (b)(6) 2022 during an osteotomy procedure and at a follow-up appointment it was discovered that the plate broke.Surgeon questioned patient on if they were following proper after care instructions and patient argued that they did follow instructions.The plate was removed on (b)(6) 2023 and a new construct was implanted.This did not initially cause any patient harm or delay in surgery.Trimed's medical advisor stated that the upg-7 used for the ulnar osteotomy procedure was too small for fixation in the ulnar shaft.It was stated that the plate was not the problem but that the size of the plate for the level of the osteotomy, thus this is not a failure of the design.Additional information was received on 06feb2023 stating that it is presumed the patient had applied pressure and weight to the affected area 2 weeks post operation.

• Brand Name: ULNAR PEG PLATE, 7-HOLE
• Type of Device: ULNAR PEG PLATE, 7-HOLE
• Manufacturer (Section D): TRIMED; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer (Section G): TRIMED; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer Contact: stephanie miranda ; 27533 avenue hopkins; santa clarita, CA 91355
• MDR Report Key: 16313537
• MDR Text Key: 308960587
• Report Number: 2031009-2023-00001
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00842188100048
• UDI-Public: 00842188100048
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K951302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UPG-7
• Device Catalogue Number: UPG-7
• Device Lot Number: SY19242
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 63 YR
• Patient Sex: Male