BEUDAMED
    FDA Adverse Event Other Summary report: N

    LOCKING SCREW, FULLY THREADED 5X30 MM

    MDR report key: 1631251 · Received March 9, 2010

    Report

    Report Number
    9610622-2010-00107
    Event Type
    Other
    Date Received
    March 9, 2010
    Date of Event
    February 18, 2010
    Report Date
    February 18, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K003018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN AT THIS TIME IF THE DEVICE WILL BE RETURNED. ADD'L INFO HAS BEEN REQUESTED AND IF REC'D WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON MEASURED FOR THE DISTAL LOCKING SCREW WHILE PERFORMING A LONG GAMMA NAIL AND REQUESTED A 5X30MM SCREW. THE HOSP RN CIRCULATOR GAVE THE SURGEON THE MEASUREMENTS AS WELL AS THE EXPIRATION DATE FOR THE SCREW. THE SURGEON GAVE THE APPROVAL TO PUT THE SCREW INTO THE STERILE FILED. ONCE THE SCREW WAS EXTRACTED FROM THE STERILE BOX, IT WAS NOTICED THAT IT LOOKED SHORTER THAN NORMAL AND REQUESTED THAT THE SCRUB TECH MEASURE IT. THE SCREW MEASURED 5X25 MM. FORTUNATELY FOR THE PT THE SCREW WAS NOT IMPLANTED. THE SURGEON DECIDED TO USE A 5X35 MM TO ENSURE LENGTH. THERE WAS NO DELAY IN SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW, FULLY THREADED 5X30 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K413006

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention