MAUDE Adverse Event Report: ARTHREX, INC. VA LOCKING SCREW, 1.4X8MM; BONE FIXATION PLATE

Model Number	VA LOCKING SCREW, 1.4X8MM
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
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 most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used during insertion of the screw.
Event or Problem Description
On 3/30/2022, it was reported by a sales representative via email that (3) ar-18714v-06 va locking screw stripped and would not lock into an ar-18714p-18 triangle plate from the ar-18700fs mini cfs kit.All three screws were removed and switched out for cortical screws from the same mini cfs kit.The plate remained in patient.This was discovered during a proximal phalanx orif procedure on (b)(6) 2022.Additional information received 4/4/2022: per sales representative, this procedure occurred on (b)(6) 2021 and an ar-18714v-06 va locking screw and an ar-18714v-08 va locking screw stripped and would not lock into triangle plate.Nothing broke inside the patient and case was completed successfully.

• Brand Name: VA LOCKING SCREW, 1.4X8MM
• 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: 19089255
• Report Number: 1220246-2024-01983
• Device Sequence Number: 7102580
• Product Code: HRS
• UDI-Device Identifier: 00888867303720
• UDI-Public: 00888867303720
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/11/2024

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, 1.4X8MM
• Device Catalogue Number: AR-18714V-08
• Device Lot Number: 1067867
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown