BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-04637

    MDR report key: 3241447 · Received July 22, 2013

    Report

    Report Number
    2520274-2013-04637
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 13, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR 1 UNKNOWN TRAUMA PRODUCT. HOWEVER, ENGINEERING BELIEVES THAT THE UNKNOWN PARTS ARE BLADES. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES HWC. (B)(6). INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    DEVICE REPORT FOR 1 UNKNOWN TRAUMA PRODUCT FROM SYNTHES (B)(4) WHO IS REPORTING AN EVENT IN (B)(6) AS FOLLOWS: A REAMER SHEARED OFF DURING USE. THE PFNA, PROXIMAL FEMUR NAIL ANTIROTATION, SYSTEM WAS CHOSEN TO STABILIZE AN INTER-TROCHANTERIC FRACTURE OF A PROXIMAL FEMUR. UPON OPENING THE FEMUR WITH THE 17.0MM REAMER THE BASE OF THE REAMER THAT COUPLES WITH THE JACOBS CHUCK SHEARED OFF RENDERING THE REAMER USELESS. ANOTHER REAMER WAS USED FROM THE SECOND SET AT THE HOSPITAL IN ORDER TO COMPLETE THE OPENING OF THE MEDULLARY CANAL. A 125 DEGREE PFNA SHORT WAS INSERTED AND UNFORTUNATELY UPON INSERTION AN IATROGENIC FRACTURE WAS PROPAGATED IN THE SUBTROCHANTERIC REGION. THE NAIL WAS SUBSEQUENTLY REMOVED AND A 130 DEGREE PFNA LONG NAIL WAS INSERTED. THE AIMING ARM WAS CHANGED TO THE 130 DEGREE INSTRUMENT AND THE GUIDEWIRE INSERTION AND REAMING FOR THE PFNA BLADE WAS PERFORMED AGAIN. FOLLOWING THIS, THE BLADE WAS CHOSEN AND INSERTED USING THE IMPACTOR FOR PFNA BLADE. ONCE INSERTED THE SURGEON WAS NOT ABLE TO LOCK THE BLADE IN ORDER TO REMOVE THE IMPACTOR. THE SURGEON HAD TO REMOVE THE BLADE AND IMPACTOR WITH FORCE. THE SURGEON INSERTED A SEPARATE PFNA BLADE WITH THE EXTRACTION SCREW FOR THE PFNA BLADE, HOWEVER HE WAS AGAIN UNABLE TO LOCK THE BLADE. ON BOTH OCCASIONS, BOTH BLADES WERE UNABLE TO BE REMOVED FROM THE INSTRUMENTS AS THE BLADE COMPONENTS WOULD ROTATE RATHER THAN UNTHREAD WHEN THE IMPACTOR/EXTRACTION SCREW WAS TURNED CLOCKWISE. THE SURGEON THEN OBTAINED AN ADDITIONAL INSTRUMENT SET, RE-REAMED THE FEMORAL NECK AND INSERTED A THIRD BLADE WITH A NEW IMPACTOR. THIS INSERTION ATTEMPT PROGRESSED AS EXPECTED AND WAS UNEVENTFUL. IT WAS ALSO NOTED THAT THE BUTTRESS NUT HAD BEEN TIGHTENED TO THE PROTECTION SLEEVE AND WAS UNABLE TO BE REMOVED. THE DEPUY-SYNTHES REPRESENTATIVE WAS NOT PRESENT AT THIS PROCEDURE AND THIS INFORMATION WAS RECEIVED FROM THE SURGEON AFTER THE CASE. ALL INSTRUMENTS LISTED HERE AND THE TWO BLADES STUCK IN THE IMPACTOR/EXTRACTION SCREWS WILL BE RETURNED ONCE DECONTAMINATED. MATERIAL HAS NOT YET BEEN RECEIVED. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 8 OF 8 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340338 HSB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention