BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITANIUM HEXED UNISCREW

    MDR report key: 5433807 · Received February 12, 2016

    Report

    Report Number
    0001038806-2016-00023
    Event Type
    Malfunction
    Date Received
    February 12, 2016
    Date of Event
    November 2, 2015
    Report Date
    January 18, 2016
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    PK072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCREW IS PART OF A ¿BUNDLED¿ ITEM. THE DRIVER TIP (RASH3N) AND UNIHT-Q OF THE ITCS41 KIT WAS RETURNED FOR REVIEW. THE TEMPORARY CYLINDER HAS NOT BEEN RETURNED. VISUAL INSPECTION HAS CONFIRMED THAT THE HEX OF THE UNIHT HAS FRACTURED. THE TIP OF THE RASH3N HAS ALSO FRACTURED. ALTHOUGH INDICATION OF USE ON THE DRIVER WAS IDENTIFIED, THE ISO-LATCH HAS NOT BEEN DAMAGED. VISUAL COMPARISON TO DRAWINGS DID NOT PROVIDE INDICATION OF A MANUFACTURING DEVIATION. THE DEVICE HISTORY RECORD FOR THE DRIVER AND THE KIT WAS REVIEWED AND THERE WAS NO INDICATION OF A MANUFACTURING DEVIATION THAT WOULD CONTRIBUTE TO THIS EVENT. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    THE DENTIST REPORTED A SCREW WAS REMOVED FROM THE PATIENT. THE RETURNED SCREW WAS FOUND FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91367 TITANIUM HEXED UNISCREW SCREW NHA BIOMET 3I 991978

    Patients

    Seq Age Sex Outcome Treatment
    1