BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM CORTEX SCREW SELF-TAPPING 50MM

    MDR report key: 3062740 · Received April 17, 2013

    Report

    Report Number
    1719045-2013-10703
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    December 9, 2011
    Report Date
    December 9, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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

    IT WAS REPORTED THAT DURING A SYNDESMOSIS PROCEDURE, THE SURGEON INSERTED SCREW. X-RAY CONFIRMED THAT THE SCREW BROKE IN THREE PIECES. ONE PIECE WAS STILL SCREWED ONTO THE BONE AND THE OTHER PIECES BROKE IN BETWEEN THE FIBULA AND TIBIA. THE SURGEON BACKED OUT THE SCREW AND RETRIEVED THE BROKEN PIECES. ALL BROKEN FRAGMENTS OF THE SCREW WERE REMOVED. THE SURGEON REPLACED THE SCREW WITH A NEW SCREW AND COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEMS. THIS REPORT IS FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164368 3.5MM CORTEX SCREW SELF-TAPPING 50MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR