MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, 2.4MM X 18MM CORTEX; BONE FIXATION SCREW/PLATE

Model Number	LOW PROFILE SCREW, 2.4MM X 18MM CORTEX
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure the surgeon had an issue with a volar distal radius plate.The distal 2.4 locking screws would not lock into the plate and just spun in place.The surgeon then took out the plate, replaced with another plate and did not want to use any of the screws from this set.No patient harm.
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 device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to improper bone prep and/or misaligned insertion.

• Brand Name: LOW PROFILE SCREW, 2.4MM X 18MM CORTEX
• Common Device Name: BONE FIXATION SCREW/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: 19271102
• Report Number: 1220246-2024-02974
• Device Sequence Number: 6968263
• Product Code: HWC
• UDI-Device Identifier: 00888867219724
• UDI-Public: 00888867219724
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/08/2024

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: LOW PROFILE SCREW, 2.4MM X 18MM CORTEX
• Device Catalogue Number: AR-8916CX24-18
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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