BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM CANNULATED SCREW LONG THREAD / 20MM

    MDR report key: 3003400 · Received February 28, 2013

    Report

    Report Number
    1719045-2013-10265
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    SYNTHES (USA) MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K962823
    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. THE MANUFACTURING INVESTIGATION REVEALED THE TOP OF THE HEAD IS DAMAGED AROUND THE CROSS SLOT FEATURE. THERE ARE LIGHT SCRATCHES/MARKS ON THE SHAFT. THE REMAINDER OF THE SCREW IS IN FAIR CONDITION. THE SPECIFICATION INVESTIGATION SHOWED THE TOP OF THE SCREW DID NOT FIT THE PROFILE DUE TO CROSS SLOT. HOWEVER THE REMAINDER OF THE HEAD PROFILE WAS WITHIN TOLERANCE. IT IS CONCLUDED SINCE A REVIEW OF THE DEVICE COULD NOT BE COMPLETED, AND NO ISSUES WERE FOUND WITH THE HEAD DIAMETER OR THE PORTION OF THE SCREW HEAD THAT CONTACTS THE WASHER MAKING THIS COMPLAINT INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT EPICONDYLE OF THE HUMEROUS PROCEDURE THE SURGEON INSERTED SCREW AND WASHER AND WAS TIGHTENING, WHEN THE WASHER BENT AND THE SCREW HEAD WENT THROUGH THE WASHER POPPED OFF. SURGEON TIGHTENED THE SCREW DOWN WITHOUT THE WASHER. ANOTHER SCREW WAS INSERTED WITH A WASHER AND WAS REMOVED AS THERE WAS A GAP BETWEEN THE HEAD AND WASHER. SURGEON REMOVED THE SCREW AND INSERTED ANOTHER WITHOUT THE WASHER AND COMPLETED THE PROCEDURE WITH NO LARGE DELAY, ABOUT 10 MINUTES. THIS REPORT IS ON THE SCREW THAT HAD A GAP WITH THE WASHER. THIS IS REPORT 3 OF 3 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86770 3.0MM CANNULATED SCREW LONG THREAD / 20MM HWC SYNTHES (USA) MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR