MAUDE Adverse Event Report: TRIMED, INC. PHALANGEAL T-PLATE, 11-HOLE

Model Number	PHT-11
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A sales rep reported on (b)(6) 2024 that he had a call with a rep explaining that during a post op appointment, the surgeon noticed that the pht-11 plate had broken through one of the screw holes.It was stated that this looked good at the first post op appointment.It was stated the patient has good motion and the fracture is healed.The surgeon is opting to leave the implant insitu and will continue to observe it and they do not believe this issue will cause any complications.

• Brand Name: PHALANGEAL T-PLATE, 11-HOLE
• Common Device Name: PHALANGEAL T-PLATE, 11-HOLE
• 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: megan rissler ; 27533 avenue hopkins; santa clarita, CA 91355
• MDR Report Key: 21107351
• Report Number: 2031009-2025-00001
• Device Sequence Number: 8153344
• Product Code: HRS
• UDI-Device Identifier: 00842188101076
• UDI-Public: 00842188101076
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2025

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: PHT-11
• Device Catalogue Number: PHT-11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2025
• 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: Other
• Patient Sex: Unknown