MAUDE Adverse Event Report: ARTHREX, INC. 2.4 X 16MM VAL SCREW, TI; BONE FIXATION PLATE

Model Number	2.4 X 16MM VAL SCREW, TI
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error of the device due to improper bone prep, misaligned insertion, prying/leveraging the device during insertion.
Event or Problem Description
On 12/09/2021 it was reported by a facility representative via e-mail that there was an issue with locking screws engaging with the ar-8916vnr-03 volar plate.This occurred during a distal radius surgery on (b)(6) 2021 when the surgeon tried using the variable angle guide to insert (3) ar-8724v-22, (2) ar-8724v-2, and (1) ar-8724v-16 screws into the ar-8916vnr-03 volar plate.Additional information requested.Additional information provided on 12/10/2021 : the device was used in the procedure but when it was realized the screws were not locking into the plate, a backup plate and screws that worked properly were used to complete the case.

• Brand Name: 2.4 X 16MM VAL SCREW, TI
• 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: 19453463
• Report Number: 1220246-2024-04784
• Device Sequence Number: 7089874
• Product Code: HRS
• UDI-Device Identifier: 00888867045606
• UDI-Public: 00888867045606
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K131474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2024

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: 2.4 X 16MM VAL SCREW, TI
• Device Catalogue Number: AR-8724V-16
• Device Lot Number: 11435123
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown