MAUDE Adverse Event Report: ARTHREX, INC. 2.4 X 18MM VAL SCREW, TI; BONE FIXATION PLATE

Model Number	2.4 X 18MM VAL SCREW, TI
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 3/31/2022, it was reported by a distributor via email that an ar-8724v-18 low profile va locking screw did not lock into the plate and passed right through the plate into the bone under the plate.Surgeon was able to remove the screw and did not have to remove the plate.This was discovered during a distal radius procedure.
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 over-torquing/over-engaging the screws during use.

• Brand Name: 2.4 X 18MM 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: 19331801
• Report Number: 1220246-2024-03405
• Device Sequence Number: 6816294
• Product Code: HRS
• UDI-Device Identifier: 00888867045613
• UDI-Public: 00888867045613
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/16/2024

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 18MM VAL SCREW, TI
• Device Catalogue Number: AR-8724V-18
• Device Lot Number: W698661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2019
• 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