MAUDE Adverse Event Report: ARTHREX, INC. VOLAR DISTAL RAD PLT TI STD RT 5H; BONE FIXATION PLATE

Model Number	VOLAR DISTAL RAD PLT TI STD RT 5H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that the volar distal radius plate broke a few weeks post-op.No further information received.Update 07-sep-2023 nroe: further information revealed that during a distal radius osteotomy a volar distal radius plate was implanted into the patient.A few weeks after the initial surgery the plate broke and had to be replaced with the same type of implant in an additional surgery on (b)(6) 2023.
Additional Manufacturer Narrative
Complaint is confirmed.Visual inspection identified that the plate was broken at hole one.Scratches were noted on both surfaces of the device, and discoloration.Functional testing was not performed due to the damage to the device.No x-rays were provided.Eight different screws were returned, and no information was provided about them.Patient specific event - the most likely cause of this failure is that the patient did not follow the doctor's instructions after release from surgery.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: VOLAR DISTAL RAD PLT TI STD RT 5H
• Common Device Name: BONE FIXATION PLATE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 17862702
• Report Number: 1220246-2023-08048
• Device Sequence Number: 5929681
• Product Code: HRS
• UDI-Device Identifier: 00888867131156
• UDI-Public: 00888867131156
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K150456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: VOLAR DISTAL RAD PLT TI STD RT 5H
• Device Catalogue Number: AR-8916VSR-05
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 09/07/2023; 02/13/2025
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 11/28/2023; 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2022
• 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