MAUDE Adverse Event Report: ARTHREX, INC. VAL KREULOCK SCREW, TI, 2.4X18; PLATE, FIXATION, BONE

Model Number	VAL KREULOCK SCREW, TI, 2.4X18
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/09/2022
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 (b)(6), 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.One unpackaged ar-8724vcl-18 screw and concomitant ar-8916vsr-06 plate were received for investigation.Visual inspection identified that the screw was locked within the threaded plate hole, and could not be removed, as the head of the screw had been stripped.Further visual evaluation revealed that the distal screw threads were also stripped.The condition of the plate threads could not be assessed.The most likely cause for the reported failure can be attributed to user error of the device due to over-torqueing/over-engaging the screw within the plate.
Event or Problem Description
On (b)(6)2022, it was reported by a sales representative via phone that when surgeon went to insert the very last ar-8724vcl-18 kreulock screw, it sunk below the distal hole of an ar-8916vsr-03 volar distal radius plate.The screw became stuck in the plate and when surgeon attempted to removed the screw, the t8 screw driver bent.Finally, surgeon has to remove all the other screws and forcibly remove the last screw which was still stuck to the plate.A new plate was opened and case was completed.This was discovered during a radius fracture procedure on (b)(6)2022.

• Brand Name: VAL KREULOCK SCREW, TI, 2.4X18
• Common Device Name: PLATE, FIXATION, BONE
• 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: 19200395
• Report Number: 1220246-2024-02507
• Device Sequence Number: 15465969
• Product Code: HRS
• UDI-Device Identifier: 00888867323971
• UDI-Public: 00888867323971
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K201132
• 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): 04/29/2024

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 KREULOCK SCREW, TI, 2.4X18
• Device Catalogue Number: AR-8724VCL-18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown