BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EX

    MDR report key: 3212863 · Received July 9, 2013

    Report

    Report Number
    2520274-2013-04088
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND.(B)(4)

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE PART WAS RECEIVED; AN EVALUATION IS CURRENTLY IN PROGRESS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PRODUCT DEVELOPMENT EVENT EVALUATION: ONE SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS AND ONE AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING WERE RETURNED. THESE TWO INSTRUMENTS ARE USED TO INSERT THE SPIRAL BLADE FOR THE RETROGRADE APPROACH IN THE TITANIUM CANNULATED RETROGRADE/ANTEGRADE FEMORAL NAIL TECHNIQUE GUIDE. THE SPIRAL BLADE INSERTER WAS JAMMED INSIDE THE AIMING ARM UPON RECEIPT. THE GOLD SLEEVE ON THE SPIRAL BLADE INSERTER HAD DENTS HOWEVER THE PARTS WERE IN OTHERWISE GOOD CONDITION. THE SPIRAL BLADE INSERTER IS DESIGNED TO ADVANCE THE SPIRAL BLADE CONNECTED VIA A CONNECTING SCREW, USING HAMMER BLOWS THROUGH THE AIMING ARM AND NAIL UNTIL IT IS FLUSH WITH THE LATERAL CORTEX. THE SPIRAL BLADE INSERTER WAS MANUFACTURED IN AUGUST 2006 AND THE AIMING ARM WAS MANUFACTURED IN NOVEMBER 2006. ALL AIMING ARMS MANUFACTURED ON OR AFTER AUGUST 2008 HAVE A DESIGN CHANGE TO AVOID BINDING OR JAMMING CONDITION TO IMPROVE THE OVERALL ENGAGEMENT OF THE SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS WHEN USED TOGETHER. THE RETURNED AIMING ARM WAS MANUFACTURED PRIOR TO THE CHANGES; THIS ISSUE IS DEEMED VALID FROM A DESIGN PERSPECTIVE.

    Description of Event or Problem · 1

    DURING A RETROGRADE FEMORAL NAILING PROCEDURE ON (B)(6) 2013, THE SURGEON WAS TRYING TO INSERT A BLADE VIA AN AIMING ARM AND A SPIRAL BLADE INSERTER. WITH THE BLADE AIMING INTO THE ARM, IT WOULD NOT GO THROUGH. THE SURGEON BACKED OUT THE INSERTER, TOOK OFF THE AIMING ARM AND INSERTED THE BLADE FREE HAND WITH AN X-RAY ASSIST. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT IS DOING WELL. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313470 SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EX LXH SYNTHES GMBH 1520675

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR