BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM TI CORTEX SCREW SELF-TAPPING 50MM

    MDR report key: 3071826 · Received April 22, 2013

    Report

    Report Number
    1719045-2013-10790
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    December 20, 2011
    Report Date
    December 20, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    PRE-AM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED BECAUSE NO LOT NUMBER WAS PROVIDED AND IT WAS NOT AVAILABLE ON THE RETURNED PRODUCT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CALCANIAL LIMB LENGTHENING PROCEDURE, THE SURGEON PRE-DRILLED WITH A 2.5 DRILL BIT, AND FULLY INSERTED THE SCREW, AND WHEN THE SCREW WAS FULLY INSERTED, THE SURGEON NOTICED THAT 2 OF THE SCREW THREADS HAD PARTIALLY PEELED OFF. HE WAS ABLE TO REMOVE THE PEELED SCREW THREADS FROM THE SURFACE, AND CONFIRMED BY X-RAY THAT THERE WERE NO PEELED THREAD FRAGMENTS IN THE BONE. THE SCREW REMAINS IMPLANTED, BUT NO FURTHER SURGERY IS INDICATED TO REMOVE ANY FRAGMENTS. THE SURGEON COMPLETED THE REST OF THE PROCEDURE WITHOUT FURTHER PROBLEM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171485 3.5MM TI CORTEX SCREW SELF-TAPPING 50MM HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR