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

Model Number	PS8
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	04/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Sales rep reported on 09apr2026 that a ps8 broke and required removal.The rep stated the removal case occurred on (b)(6) 2026, the patient did not fall, the patient is larger weighing over 300 pounds, seems to be young but no other medical issues are known.It is unknown if the patient was following all post-op instructions.Additionally, the surgeon opted to replace the trimed plate with a larger synthes plate.The rep attempted to retrieve the broken plate however the facility had already discarded it.

• 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: 25074698
• Report Number: 2031009-2026-00006
• Device Sequence Number: 21438755
• Product Code: HRS
• UDI-Device Identifier: 00842188100840
• UDI-Public: 00842188100840
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K060041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 05/04/2026

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 Catalogue Number: PS8
• Device Lot Number: 30012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 05/04/2026
• 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