BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE INSERTER

    MDR report key: 3062375 · Received April 16, 2013

    Report

    Report Number
    2530088-2013-10423
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    September 22, 2011
    Report Date
    September 22, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. PRODUCT DEVELOPMENT EVALUATION REVEALS THE PART WAS RECEIVED WITH NUMEROUS DENTS AND GOUGES ON THE GOLD HANDLE, THE TOP OF THE ALIGNMENT INDICATOR, THE TOP AND BOTTOM SURFACES OF THE ALIGNMENT INDICATOR EARS AND THE KNURLED AREA OF THE SET SCREW. THE ALIGNMENT INDICATOR SPINS FREELY AROUND THE SHAFT AND THE SET SCREW CAN BE TIGHTENED TO LOCK ROTATION AND LOOSENED FOR FREE ROTATION. THE ALIGNMENT INDICATOR WAS SUCCESSFULLY REMOVED AND THE ALIGNMENT PIN IS BROKEN OFF AND MISSING. THIS ISSUE WAS PREVIOUSLY NOTED AND WHEN THE HAMMER MISSES THE HEAD OF THE COUPLING SCREW, THE EARS OF THE INDICATOR CAN BE ACCIDENTALLY HIT BY THE HAMMER. THIS MAY CAUSE THE PIN IN THE INDICATOR TO BE DAMAGED AND THEREFORE THE INDICATOR MAY SPIN FREELY OR IT MAY BECOME JAMMED. THIS IS DUE TO A KNOWN TECHNIQUE ISSUE RELATING TO THE USE OF THE HAMMER. THIS CAN BE CAUSED IF THE HAMMER MISSES THE HEAD OF THE HELICAL BLADE COUPLING SCREW AND INSTEAD HITS THE EARS OF THE INDICATOR. IT DOES NOT CAUSE A LOSS OF FUNCTION DURING THE CASE. THE PURPOSE OF THE INDICATOR IS TO CAPTURE THE GOLD HANDLE ON THE INSERTER. IF THE TOP SPINS FREELY IT IS STILL HELD IN PLACE AND DOES NOT FALL OFF OF THE HELICAL BLADE INSERTER AND THEREFORE THE CASE CAN BE COMPLETED WITHOUT INCIDENT. IF THE INDICATOR BECOMES JAMMED IT STILL CAPTURES THE GOLD HANDLE AND THE CASE CAN BE EASILY COMPLETED. THE COMPLAINT CONDITION IS CAUSED BY INADVERTENT HAMMER BLOWS TO THE ALIGNMENT INDICATOR AND HAS BEEN EVALUATED ON PREVIOUS COMPLAINTS AND DETERMINED TO BE INVALID. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    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. ORIGINAL AWARENESS DATE IS (B)(4) 2011. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE TROCHANTERIC NAILING OF A PROXIMAL FEMUR, THE SURGEON TRIED TO REMOVE THE HELICAL BLADE WITH THE INSERTER INSTEAD OF THE EXTRACTOR AND THE PIN ON THE BACK OF THE INSERTER BROKE OFF. THE PATIENT WAS UNHARMED.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162449 HELICAL BLADE INSERTER LXH SYNTHES BRANDYWINE 6339365

    Patients

    Seq Age Sex Outcome Treatment
    1