BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 2993946 · Received March 8, 2013

    Report

    Report Number
    2530088-2013-10230
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    January 29, 2012
    Report Date
    January 29, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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 INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    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 AN ORIF RIGHT FEMUR PROCEDURE, THE THREADED PORTION OF THE DRIVING CAP BROKE OFF INTO THE RADIOLUCENT INSERTION HANDLE. THE BROKEN FRAGMENT IS STUCK IN THE RADIOLUCENT INSERTION HANDLE AND WAS UNABLE TO BE RETRIEVED. SURGEON THEN HAMMERED THE RADIOLUCENT INSERTION HANDLE INSTEAD TO COMPLETE THE PROCEDURE. DURING THE INSERTION OF THE HELICAL BLADE, THE HEAD OF THE HELICAL BLADE COUPLING SCREW POPPED OFF WHILE THE SURGEON WAS HAMMERING THE HELICAL BLADE COUPLING SCREW. NOTHING BROKE INTO THE PATIENT. ALL BROKEN FRAGMENTS WERE RETRIEVED EXCEPT FOR THE BROKEN FRAGMENT OF THE DRIVING CAP WHICH REMAINS IN THE AIMING ARM. SURGEON COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEMS. THIS IS REPORT 2 OF 3 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98569 HELICAL BLADE COUPLING SCREW LXH SYNTHES BRANDYWINE 5010025

    Patients

    Seq Age Sex Outcome Treatment
    1