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

Model Number	UPG-7
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/16/2023
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: 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
• Report Number: 2031009-2023-00001
• Device Sequence Number: 6279413
• Product Code: HRS
• UDI-Device Identifier: 00842188100048
• UDI-Public: 00842188100048
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K951302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: UPG-7
• Device Catalogue Number: UPG-7
• Device Lot Number: SY19242
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2023
• 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 Age: 63 YR
• Patient Sex: Male