BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP DHHS INSERTER GUIDE

    MDR report key: 3003443 · Received February 28, 2013

    Report

    Report Number
    2530088-2013-10213
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RECEIVED FOR EVALUATION. ONE OF THE PINS WAS MISSING AND THE OTHER PIN HAD SIGNS OF WEAR AND SLIGHT DAMAGE. THE SWIVEL PLATE EXHIBITED MARKS, NICKS, AND SCRATCHES ON VARIOUS SURFACES. THE GUIDE SHAFT HAD SOME MINOR SCUFF MARKS AND NICKS. THE DEVICE PASSED SPECIFICATION INVESTIGATION. BASED ON THE EVALUATIONS PERFORMED, A ROOT CAUSE WAS INDETERMINATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION OF THE LEFT HIP, THE SURGEON WAS INSERTING THE DYNAMIC HELICAL HIP SYSTEM (DHHS) HELICAL BLADE WITH THE LOCKING COMPRESSION PLATE DHHS INSERTER GUIDE AND THE GUIDE BROKE AND FELL APART AS IT WAS REMOVED. TWO SCREWS CAME OUT, AND ALL PIECES EXCEPT ONE SCREW WAS RETRIEVED. FLUOROSCOPY WAS USED, AND THE SCREW WAS NOT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86995 LCP DHHS INSERTER GUIDE FZX SYNTHES BRANDYWINE 5153809

    Patients

    Seq Age Sex Outcome Treatment
    1