MAUDE Adverse Event Report: ARTHREX, INC. VA LOCKING SCREW, 1.4X12MM; BONE FIXATION PLATE

Model Number	VA LOCKING SCREW, 1.4X12MM
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/02/2023
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 is confirmed based on the customer-provided photo, which shows that the threads of the screw ar-18714v-13 were stripped/damaged.However, without the return of the device for physical evaluation, the most likely cause for the reported failure can be attributed to user error of the device due to misalignment insertion and/or prying/leveraging the screw during insertion.
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via email that (3) 1.4mm locking screws would not lock into the plate and would spin.The surgeon was using an eight-hole triangle plate implanted in the patient.The screw would not lock in the shaft and on the triangle portion of the plate.When the surgeon attempted to lock the screw in the locking hole and the screw would spin; however, the surgeon drilled a hole right next to the previous one, and the screw would lock without any issues.This was discovered during a procedure.Additional information received on 3/13/2023: the three faulty screws were an ar-18714v-13 va locking screw, 1.4x13mm, an ar-18714v-08 va locking screw, 1.4x8mm, and an ar-18714v-12 va locking screw, 1.4x12mm.All three were attempted to be inserted and were not implanted due to spinning and not locking into an ar-18714p-18 triangle plate, 1.4mm.The case was completed by using two ar-18714v-12 va locking screw, 1.4x12mm, an ar-18714v-06 va locking screw, 1.4x6mm, three ar-18714v-10 va locking screw, 1.4x10mm and two ar-18714v-09 va locking screw, 1.4x9mm.This was discovered during a 4th and 5th proximal phalanx fracture procedure on (b)(6) 2023.

• Brand Name: VA LOCKING SCREW, 1.4X12MM
• 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: 19296663
• Report Number: 1220246-2024-03144
• Device Sequence Number: 5665396
• Product Code: HRS
• UDI-Device Identifier: 00888867303683
• UDI-Public: 00888867303683
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K191326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2024

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: VA LOCKING SCREW, 1.4X12MM
• Device Catalogue Number: AR-18714V-12
• Device Lot Number: 2684542
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown