MAUDE Adverse Event Report: TRIMED, INC. VOLAR WRIST HOOK PLATE, 6-HOLE

Model Number	WHV-6
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Oversedation (1990)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Sales rep reported on (b)(6) 2026 that the surgeon attached a 6-hole volar hook plate to the radius with a single 2.3 torx screw through the slot in the plate.Attention was then directed to the dorsal side of the radius, where a 6-hole dorsal hook plate was attached with a 2.3 torx screw.This screw was inserted until it protruded on the volar aspect of the radius and impacted the emplaced volar hook plate.This impaction forced the volar hook plate off the bone, acting as a lever around the head of the screw affixing it in place, and pushing it over and off the screw and detaching the distal hooks from bone.The volar hook plate required removal from the surgical site and could not be reinstalled or replaced due to the comminution of the bone around the insertion site and subsequent instability associated with the forced removal of the plate tines.The remaining volar screw was then prominent and required removal; this posed some difficulty for the surgeon as she struggled to get the screwdriver to seat into the head of the screw.The head of the screw may have been bent up while passing through the slot in the plate; the slot in the plate appears to have been widened at the point where the screw head passed through.As the site for placement of hook plate tines was no longer viable for fixation, the surgeon used a 42mm volar buttress pin with a 5-hole washer to achieve fixation on the volar surface of the distal radius.Fixation with the dorsal hook plate was not affected, and more screws were added to complete its attachment.Additionally, a 7-hole right radial peg plate was used to stabilize the radial styloid.Additional information was provided on 20feb2026 that this caused over a 30-minute delay in surgery due to the surgeon having to verify that another hook plate could not be reinstalled, they had to re-establish the reduction and install a volar buttress pin and wireform plate to complete the surgery.It was stated that this issue contributed to additional comminution of the distal radius where the hooks of the hook plate had been seated.

• Brand Name: VOLAR WRIST HOOK PLATE, 6-HOLE
• Common Device Name: VOLAR WRIST HOOK PLATE, 6-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: 24591375
• Report Number: 2031009-2026-00003
• Device Sequence Number: 8933508
• Product Code: HRS
• UDI-Device Identifier: 00842188101007
• UDI-Public: 00842188101007
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K951302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/13/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: WHV-6
• Device Catalogue Number: WHV-6
• Device Lot Number: BF19029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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