MAUDE Adverse Event Report: ARTHREX, INC. VAL SCREW, TI, 2.4 X 12MM; BONE FIXATION PLATE

Model Number	VAL SCREW, TI, 2.4 X 12MM
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, while the surgeon was using the mini cfs set, the surgeon has an issue with two of the 2.4x12mm val locking screws, ar-18724v-12.The surgeon drilled 3 holes in the v plate and when tried to tighten the val screws into the hole, they would not engage.The surgeon had to switch the two 2.4x12mm screws and replace them with the 2.4x11mm screw and a 2.4x12mm screw after they did not lock into multiple different holes of the plate.
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.One unpackaged ar-18724v-12 locking screw (no batch number provided) was received for investigation.Visual inspection under microscope identified the presence of bone remnants lodged within the locking threads, inferior to the hex.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device when cleaning and disinfecting by user.

• Brand Name: VAL SCREW, TI, 2.4 X 12MM
• 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: 19500822
• Report Number: 1220246-2024-05452
• Device Sequence Number: 7870575
• Product Code: HRS
• UDI-Device Identifier: 00888867314801
• UDI-Public: 00888867314801
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K220937
• 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): 06/10/2024

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: VAL SCREW, TI, 2.4 X 12MM
• Device Catalogue Number: AR-18724V-12
• Device Lot Number: 2685631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2019
• 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