BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L5

    MDR report key: 3161841 · Received June 11, 2013

    Report

    Report Number
    2520274-2013-03299
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    June 28, 2012
    Report Date
    June 28, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    JEY
    PMA / PMN Number
    K022012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE MEASURABLE DIMENSIONS OF THE BROKEN CORTEX SCREW WERE CHECKED AND FOUND IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND SPECIFICATION. THE VISUAL INSPECTION REVEALED SCREW HEAD RECESSES ON BOTH SCREWS SHOWING WEAR AND DAMAGES POINTING TO THE FACT THAT THE SCREWS WERE SUBJECTED TO MECHANICAL OVERLOADING. THE MICROSCOPIC INVESTIGATION OF THE BROKEN SURFACES SHOWS HOMOGENOUS MATERIAL STRUCTURES; NO ANOMALIES WERE FOUND. THEREFORE WE CONSIDER THESE BREAKAGES TO BE CAUSED DURING MECHANICAL OVERLOADING SITUATIONS. THE COMPLAINT HAS BEEN DETERMINED TO BE INDETERMINATE.

    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. (B)(4)

    Description of Event or Problem · 1

    TWO SCREWS BROKEN DURING THE INSERTION TO THE PATIENT'S CRANIUM. THIS IS 1 OF 2 REPORTS FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262979 CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L5 JEY SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1