BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.0MM/8.0MM PROTECTION SLEEVE 188MM

    MDR report key: 3003480 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10440
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 29, 2011
    Report Date
    January 29, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    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 FILLING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. SUBJECT DEVICE HAS BEEN REC'D AND EVALUATED. THE MFG RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL REC'D DEVICES SHOWED MARKS OF FORCIBLE USE. THE PROTECTION SLEEVES HAD VISIBLE MARKS OF MISUSE CAUSED BY FORCIBLE ATTEMPTS TO STRIKE THEM INTO THE DEFORMED BORES OF THE AIMING ARMS. THE INTACT AND MEASURABLE DIAMETERS DID FULLY MEET TO OUR SPECIFICATIONS. THIS COMPLAINT IS DEEMED INVALID FROM A MFG STANDPOINT.

    Description of Event or Problem · 1

    DURING A LATERAL ENTRY FEMORAL NAIL PROCEDURE FOR PROXIMAL FEMUR FRACTURE, THE PROTECTION SLEEVE DID NOT FIT THROUGH THE 120 DEGREE ANTE-GRADE HOLE (FOR THE LATERAL ENTRY FEMORAL NAIL) IN THE STANDARD INSERTION HANDLE. THE SURGEON TRIED THREE DIFFERENT SLEEVES AND THREE DIFFERENT HANDLES FROM DIFFERENT SETS. HE HAD TO AGGRESSIVELY MALLET THE SLEEVE INTO THE HANDLES AND USE STERILE MINERAL OIL. ONE OF THE SLEEVES WENT HALF WAY IN, AND WAS MALLETED AGGRESSIVELY. THE SURGEON COMPLETED THE PROCEDURE SUCCESSFULLY. THE SURGEON COMPLETED THE PROCEDURE SUCCESSFULLY. THIS EVENT DID NOT IMPOSE ANY HARM ON THE PT. THIS INCIDENT EXTENDED THE SURGERY BY APPROXIMATELY 30 MINUTES. THIS COMPLAINT IS ON THE FIRST PROTECTION SLEEVE. THIS REPORT IS 4 OF 6 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87168 12.0MM/8.0MM PROTECTION SLEEVE 188MM LXH SYNTHES GMBH 4786948

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention