MAUDE Adverse Event Report: TRIMED, INC. LOCKING PLATE, STRAIGHT, 8-HOLE

Model Number	PS8
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Distributor reported on (b)(6) 2025 that there was a broken ps8 found in an x-ray on (b)(6) 2025 after the patient arrived at a follow-up appointment reporting pain.The original implant date was (b)(6) 2025 and it was stated that according to the attending physician, the patient was not very cooperative with the post-operative protocol.Therefore, after the surgery but prior to the follow up x-ray, the doctor decided to apply an acrylic plaster cast to immobilize the wrist and forearm.The broken plate was discovered after the plaster cast was applied so the doctor requested surgical intervention on (b)(6) 2025 for the removal of material and that the patient requested the change of material type from steel to titanium.It was reported to trimed on (b)(6) 2025, that there is no evidence suggesting a product defect.Preliminary information indicates that the patient suffered a fall postoperatively, which may explain the event.However, the case is being followed locally for a complete evaluation.There was about a 0-5 minute delay in surgery due to the surgeons schedule but the removal was successful.Due to patient discomfort and non-union there is a reported adverse event.

• Brand Name: LOCKING PLATE, STRAIGHT, 8-HOLE
• Common Device Name: LOCKING PLATE, STRAIGHT, 8-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: 23699869
• Report Number: 2031009-2025-00026
• Device Sequence Number: 18430016
• Product Code: HRS
• UDI-Device Identifier: 00842188100840
• UDI-Public: 00842188100840
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K060041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PS8
• Device Lot Number: SY24012
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 12/02/2025
• 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: Required Intervention
• Patient Sex: Unknown