BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVER-CRUCIF NOT SELF-HOLDING F/CORT

    MDR report key: 3180681 · Received June 20, 2013

    Report

    Report Number
    2520274-2013-03587
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    August 4, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PRODUCT IS NOT SOLD OR DISTRIBUTED IN THE US.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 EVALUATION REVEALED THAT ALL SEGMENTS OF THE CROSS COMPLETELY BROKE OFF. A HIGH FORCE WHEN THE SCREWDRIVER WAS NOT POSITIONED CORRECTLY PROBABLY CAUSED THE DAMAGE TO THE TIP WHEN USING THE SCREWDRIVER. ON THE GROUND OF SEVERAL NOTIFICATIONS FROM THE MARKET, OUR PRODUCT DEVELOPMENT CENTER DECIDED TO RE-ASSESS THE DESIGN. HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP IS BROKEN OFF. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280784 SCRDRIVER-CRUCIF NOT SELF-HOLDING F/CORT HXX SYNTHES USA 1653949

    Patients

    Seq Age Sex Outcome Treatment
    1