MAUDE Adverse Event Report: ARTHREX, INC. VOLAR DISTAL RAD PLT TI STD LT 3H; BONE FIXATION PLATE

Model Number	VOLAR DISTAL RAD PLT TI STD LT 3H
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
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
On (b)(6) 2023, it was reported by a sales representative via email that an ar-8916vsl-03 volar distal radius plate holes appeared to be larger than the distal holes.When the surgeon attempted to lock a 2.4mm screw, it pushed past the holes, unable to be locked.This was discovered during a distal radius orif procedure on (b)(6) 2023.Additional information requested.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, the most likely cause for the reported failure can be attributed to a manufacturing issue; however, due to the device not being returned, we are unable to confirm the reported event.

• Brand Name: VOLAR DISTAL RAD PLT TI STD LT 3H
• 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: 17699945
• Report Number: 1220246-2023-07811
• Device Sequence Number: 6719264
• Product Code: HRS
• UDI-Device Identifier: 00888867130999
• UDI-Public: 00888867130999
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K150456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VOLAR DISTAL RAD PLT TI STD LT 3H
• Device Catalogue Number: AR-8916VSL-03
• Device Lot Number: 15040312
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2023
• 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
• Patient Sex: Unknown