BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED CRUCIFORM SCREWDRIVER

    MDR report key: 3041668 · Received April 8, 2013

    Report

    Report Number
    2530088-2013-10379
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    August 11, 2011
    Report Date
    August 12, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. ORIGINAL AWARENESS DATE IS (B)(6) 2011. PLACEHOLDER.

    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT DEVELOPMENT EVALUATION REVEALED THAT THE DESIGN IS ADEQUATE FOR INTENDED USE. THERE ARE NO ADDITIONAL COMPLAINTS IN THE 2 YEAR HISTORY AND THE PART NOTED ON THE COMPLAINT IS OVER 12 YEARS OLD (MANUFACTURED IN FEB 1999). THE RETURNED DEVICE HAS TWO PRONGS BROKEN OFF THE CRUCIFORM AND ONE OF THE OTHER TABS IS SLIGHTLY DEFORMED AT THE VERY TIP WHICH INDICATES THAT THE SCREWDRIVER MAY NOT HAVE BEEN FULLY SEATED WHEN USED. THIS COULD CAUSE UNEVEN STRESS IN THE CRUCIFORM TIPS. DESIGN IS ACCEPTABLE AND THERE ARE NO OTHER ISSUES NOTED WITH THIS INSTRUMENT IN THE 2 YEAR HISTORY. SINCE THE SPECIFIC DETAILS OF HOW THIS WAS USED ARE NOT KNOWN AND THE AGE OF THE INSTRUMENT, THIS IS DEEMED INDETERMINATE.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR THIS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, SURGEON WAS INSERTING A 3.0MM CANNULATED SCREW AND TWO PRONGS BROKE OFF OF THE SCREWDRIVER TIP. ALL BROKEN PIECES WERE RETRIEVED AND THE SURGEON USED AN ALTERNATE SCREWDRIVER TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143998 CANNULATED CRUCIFORM SCREWDRIVER HXX SYNTHES BRANDYWINE A4JK567

    Patients

    Seq Age Sex Outcome Treatment
    1