BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 100MM

    MDR report key: 2032603 · Received March 23, 2011

    Report

    Report Number
    3003506883-2011-00008
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFO WAS NOT PROVIDED DURING THE INITIAL REPORT. ADDITIONAL INFO HAS BEEN REQUESTED. SUBJECT DEVICE WAS NOT IMPLANTED AND/OR EXPLANTED. SYNTHES IS UNABLE TO PROVIDE THE DATE OF MANUFACTURE AS NO PRODUCT WAS RECEIVED AND NO LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER A DEVICE HISTORY RECORDS REVIEW COULD NOT BE REQUESTED.

    Description of Event or Problem · 1

    DURING A RIGHT HIP FRACTURE PROCEDURE, SURGEON INSERTED THE 11 MM 130 DEGREE TI CANN TROCHANTERIC NAIL AND WAS IN THE PROCESS OF INSERTING THE 11.0 MM HELICAL BLADE WHEN THE HELICAL BLADE GOT STUCK. SURGEON IMPACTED THE BLADE TO TRY TO INSERT FURTHER WITHOUT SUCCESS. SURGEON THEN STARTED TO BACKSLAP THE BLADE TO REMOVE WITHOUT SUCCESS. SURGEON TRIED TO USE A SCREWDRIVER TO LOCK DOWN THE LOCKING MECHANISM WITH NO SUCCESS. AN X-RAY WAS TAKEN TO SEE IF THE PROBLEM COULD BE LOCATED AND NOTHING WAS FOUND IMPEDING THE BLADE. SURGEON REMOVED THE BLADE AND NAIL WITH THE REMOVAL DEVICE, SELECTED ANOTHER NAIL AND BLADE AND COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEMS. THE PROCEDURE TOOK APPROX 2 HOURS. THIS IS TWO OF TWO REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11.0MM TI HELICAL BLADE 100MM TI HELICAL BLADE HSB SYNTHES ELMIRA NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention NAIL