BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-03444

    MDR report key: 3183154 · Received June 21, 2013

    Report

    Report Number
    2520274-2013-03444
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 11, 2012
    Report Date
    June 11, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PSI IMPLANTATION, WHILE PUTTING IN THE SELF-DRILLING SCREWS, TWO SCREW HEADS SNAPPED OFF. THE DETACHED HEADS WERE ON THE SCREWDRIVER BLADE, AND THE SCREW THREADS WERE LEFT IN THE CRANIUM. THE CRANIUM WAS VERY THICK, AND THE THUS THE SCREW HEADS SNAPPED OFF DUE TO EXCESSIVE FORCE APPLICATION. THE SURGEON WAS THEN ADVISED TO USE THE DRILL BIT FOR PILOT HOLES WITH NO FURTHER ISSUES. THE PATIENT WAS NOT HARMED, NOR WAS THERE ANY DEBRIS FROM THE SCREW HEAD LEFT INSIDE THE PATIENT. THE SURGEON OPTED NOT TO REMOVE THE BROKEN SCREW THREADS AS THERE WERE NOT IN ANY WAY HARMING THE PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284004 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1