BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE 300X160MM

    MDR report key: 2091390 · Received May 5, 2011

    Report

    Report Number
    9610622-2011-00207
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, A CONSULTANT WITH STRYKER (GAMMA NAIL) WAS OPERATING ON A WOMAN WITH A HIP FRACTURE. AFTER, REDUCING THE FRACTURE AND PREPARING THE FEMORAL CANAL, SURGEON ASKED ME FOR GAMMA NAIL. THE CIRCULATING NURSE OPENED THE IMPLANT AND AS THE SCRUB NURSE WAS ATTACHING THE NAIL TO THE GAMMA 3 TARGET ARM, SHE NOTICED THERE WAS CRACK ON THE UNDERSIDE OF THE TARGET ARM. WE PUT THE TARGET ARM ASIDE AND USED ONE FROM ANOTHER GAMMA NAIL SET. THE CRACKED TARGET ARM NEVER TOUCHED THE PATIENT AND THE SURGERY WENT WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET DEVICE 300X160MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA KP246628

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other