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	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 6/12/2024, it was reported by a sales representative via email that distal 2.4 screws were going through an ar-8916vsl-03 volar distal radius plate during insertion.The plate was swapped for a new ar-8916vsl-03 volar distal radius plate, but the screws were still going through the plate.The issue occurred even though the surgeon used a torque limiter driver to insert the screw.This was discovered during a distal radius procedure on (b)(6) 2024.Additional information received on 6/24/2024: the case was completed by using a new plate and screws.The case was delayed thirty minutes; however, additional anesthesia was not needed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.Upon visual inspection, it was observed that the threads of one hole were stripped/damaged.Functional testing was performed with screws 2.4 mm, and screws locked in the volar distal radius plate, ti, standard, left, 3 hole as required.However, the screw did not lock in one of the holes where the threads were damaged.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces, misaligned insertion and not following the screw/holes angles; prying/leveraging the device during insertion.

• 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: jared engle ; 8009337001
• MDR Report Key: 19701619
• Report Number: 1220246-2024-06660
• Device Sequence Number: 7655618
• Product Code: HRS
• UDI-Device Identifier: 00888867130999
• UDI-Public: 00888867130999
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 09/26/2024

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: 12097119
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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