BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX INC PEEK TENODESIS SCREW WITH DISPOSABLE SHEATH 7X20MM

    MDR report key: 18826331 · Received March 1, 2024

    Report

    Report Number
    MW5152261
    Event Type
    Injury
    Date Received
    March 1, 2024
    Date of Event
    February 14, 2024
    Report Date
    February 28, 2024
    Manufacturer
    ARTHREX MANUFACTURING INC.
    Product Code
    MAI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A PATELLAR LIGAMENT REPAIR A POLYETHERETHERKETONE SCREW WAS UTILIZED. THE INITIAL SIZED POLYETHERETHERKETONE SCREW WAS NOT AN ADEQUATE FIT AND AS THE SURGEON REMOVED THE SCREWDRIVER/GUIDEWIRE/POLYETHERETHERKETONE SCREW, IT WAS NOTICED THAT THE SCREW WAS NO LONGER ON THE END OF THE SCREWDRIVER. REVIEW OF THE SURGICAL SITE AND SURROUNDING AREAS DID NOT LOCATE SCREW. XR, C-ARM, FLUOROSCOPY UNABLE TO IDENTIFY RETAINED FOREIGN OBJECT. MAGNETIC RESONANCE IMAGING AFTER CASE DID LOCATE PLASTIC SCREW WITHIN PATELLAR POUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1881881 ARTHREX INC PEEK TENODESIS SCREW WITH DISPOSABLE SHEATH 7X20MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX MANUFACTURING INC. AR-4020P-07 15155255

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention