BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD INSERTION HANDLE

    MDR report key: 3083445 · Received April 29, 2013

    Report

    Report Number
    2530088-2013-10506
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    June 4, 2012
    Report Date
    June 4, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE TANG IS BROKEN OFF AS NOTED. THERE ARE NUMEROUS DENTS ON THE UNDERSIDE OF THE INSERTION HANDLE AND METAL BURRS HAVE BEEN MOVED INTO THE HOLE. THERE IS ALSO ONE LARGE DENT ON THE TOP OF THE HOLE THAT HAS PUSHED A BURR INTO THE HOLE. A PROTECTION SLEEVE CANNOT BE INSERTED THROUGH THE HOLE. THERE ARE SOME MINOR DENTS AND ON THE FRONT EDGE OF THE REAR DRIVING CAP MOUNTING HOLE. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE. THIS HANDLE WAS MADE PRIOR TO THE DESIGN CHANGE AND PRIOR COMPLAINTS WERE DISPOSITIONED VALID FOR THIS CONDITION SO THIS IS VALID AND THE REQUIRED CORRECTIVE ACTION HAS BEEN IMPLEMENTED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORIF OF LEFT FEMUR PROCEDURE, AFTER THE NAIL WAS INSERTED, THE METAL NOTCH ON THE INSERTION HANDLE THAT MATES WITH THE NAIL BROKE OFF. THE BROKEN FRAGMENT WAS RETRIEVED. SURGEON USED ANOTHER LOCKING OPTION TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. NO ADVERSE EFFECT TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184459 STANDARD INSERTION HANDLE LXH SYNTHES BRANDYWINE 4819614

    Patients

    Seq Age Sex Outcome Treatment
    1