BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI CANNULATED MATRIX SCREW 35MM THREAD LENGTH

    MDR report key: 3083752 · Received April 29, 2013

    Report

    Report Number
    2530088-2013-10555
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    July 18, 2012
    Report Date
    July 18, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. 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. (B)(4). THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THE 35 MM MATRIX SCREW WAS RECEIVED WITH NO LOT NUMBER REFERENCED. APPROXIMATELY SEVENTY FIVE PERCENT OF THE THREAD PEELED FROM SCREW HEAD AND NICKS WERE NOTED ON THE THREAD FACE. NEITHER THE THREAD NOR THE MINOR DIAMETER COULD BE MEASURED BECAUSE OF DAMAGE. DIMENSION IS UNOBTAINABLE, AND THE COMPLAINT IS DEEMED INDETERMINATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SURGEON WAS IMPLANTING THE PEDICLE SCREW, THE TOP THREADED PORTION OF THE SCREW BROKE, CAUSING THE HOLDING SLEEVE TO SLIP OFF. NO FRAGMENTS BROKE INTO THE PATIENT, NOTHING TO RETRIEVE. SURGEON USED A DIFFERENT SCREW AND COMPLETED PROCEDURE WITH NO FURTHER PROBLEM, NO HARM TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183946 7.0MM TI CANNULATED MATRIX SCREW 35MM THREAD LENGTH NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR