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	08/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a distal radius osteotomy revision surgery was performed on (b)(6) 2023, to replace a broken-off volar distal radius plate.A few weeks after the revision surgery the plate broke again a second time and had to be replaced again.A plate from a competitor was used to finish the surgery successfully and this surgery was performed on (b)(6) 2023.The broken implant was completely retrieved from patient.
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.
Additional Manufacturer Narrative
One unpackaged ar-8916vsr-05 batch# 13755445 was received for investigation.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.The most likely cause of this failure can be attributed to environmental due to a patient specific event that the patient did not follow the doctor's instructions after release from surgery.Complaint allegation is confirmed.

• 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: 17862862
• Report Number: 1220246-2023-08052
• Device Sequence Number: 5578371
• 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
• Report Date (Section B): 02/26/2025

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
• Device Lot Number: 13755445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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