BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM TI CANNULATED FEMORAL NAIL 440MM

    MDR report key: 2820715 · Received November 6, 2012

    Report

    Report Number
    8030965-2012-01196
    Event Type
    Injury
    Date Received
    November 6, 2012
    Report Date
    October 9, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDN
    PMA / PMN Number
    K954856
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. X-RAYS RECEIVED. A MANUFACTURING EVALUATION WAS CONDUCTED. THE DEVICE ARRIVED WITH THE LOCKING SLEEVE ATTACHED TO THE NAIL. THE TWO COULD NOT BE SEPARATED DUE TO DAMAGE ON THE SLOT OF THE LOCKING SLEEVE AND THE NAIL. THE LOT NUMBER IS UNKNOWN BECAUSE IT IS HIDDEN UNDER THE LOCKING SLEEVE. THE WIDTH OF THE CUT OUT FOR THE BLADE COULD BE CHECKED AND FOUND TO MEET THE SPECIFICATIONS AS PER DRAWING. ALL OTHER DIMENSION CANNOT BE MEASURED BECAUSE OF THE JAMMED LOCKING SLEEVE. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED. A REVIEW OF THE PRODUCT DRAWINGS AND COMPLAINT HISTORY SHOW THAT THE DESIGN IS ADEQUATE FOR THE INTENDED USE. ADDITIONALLY, THE RISK ASSESSMENT APPROPRIATELY ADDRESSES THIS EVENT. TWO FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT ARE THE DAMAGE SUSTAINED TO THE BLADE DURING INSERTION, EVIDENT ON BOTH THE BLADE AND LOCKING SLEEVE, AND THE OFF-INDICATION USE OF THIS IMPLANT. ACCORDING TO THE TECHNIQUE GUIDE ((B)(4)), THE SPIRAL BLADE IS ONLY INDICATED FOR SUBTROCHANTERIC FRACTURES. THE X-RAYS PROVIDED INDICATE THE PRODUCT WAS USED FOR A TRANSVERSE INTERTROCHANTERIC FRACTURE.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING A HARDWARE REMOVAL PROCEDURE. THE PATIENT WAS IMPLANTED WITH A TITANIUM FEMORAL NAIL WITH SPIRAL BLADE ON (B)(6) 2012. POST-OPERATIVELY, THE PATIENT PRESENTED TO THE SURGEON WITH PAIN AND LIMITED MOBILITY. X-RAY REVEALED PART OF THE BLADE HAD BROKEN OFF CAUSING THE FEMORAL NECK TO COLLAPSE. THE PATIENT WAS RETURNED TO THE OR ON (B)(6) 2012 FOR REMOVAL OF ALL HARDWARE. A BROKEN PORTION OF THE BLADE IS LODGED IN THE FEMORAL HEAD AND COULD NOT BE REMOVED. THE PATIENT WAS REVISED TO HEMI-HIP ARTHROPLASTY. THIS IS REPORT #2 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12MM TI CANNULATED FEMORAL NAIL 440MM FEMORAL NAIL JDN SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention