BEUDAMED
    FDA Adverse Event Other Summary report: N

    1.5X7MM HT SD X-DRIVE SCREW

    MDR report key: 1182423 · Received September 12, 2008

    Report

    Report Number
    1032347-2008-00060
    Event Type
    Other
    Date Received
    September 12, 2008
    Report Date
    August 19, 2008
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    K953385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. SPECIFIC DOCTORS WHO EXPERIENCED THE SCREW BREAKAGE WAS NOT GIVEN. ACCORDING TO LOCAL SALES REPRESENTATIVE, THE HOSPITAL SWITCHED TO A COMPETITOR'S PRODUCT, AND EXPERIENCED THE SAME RESULTS (SCREWS BREAKING). CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. ALSO RECEIVED COMPLAINT FOR 5MM SCREWS.

    Description of Event or Problem · 1

    RECEIVED COMPLAINT SCREWS ARE BREAKING WHILE INSERTING, AND IN SOME CASES THE TIP OF THE SCREW REMAINED IMPLANTED. UNKNOWN HOW MANY SCREWS HAVE BROKEN OR HOW MANY TIPS HAVE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.5X7MM HT SD X-DRIVE SCREW BONE SCREW HWC BIOMET MICROFIXATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREWS WOULD HAVE BEEN TO HOLD A PALTE| UNK WHAT PLATE MAY HAVE BEEN USED.