BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WUBU MINI SCREWS, C-F, S-T, 1.7X6

    MDR report key: 1833318 · Received September 13, 2010

    Report

    Report Number
    8010177-2010-00304
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 9, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS, BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THOUGH THERE WAS A SPACE TO INSERTED THE SCREW INTO THE PT'S BONE, THE HEAD OF THE FIRST USE SCREW WAS BROKEN. THE TIP OF THE SCREW REMAINED IN THE BONE. SO, THOUGH THE SURGEON USED THE SECOND USE SCREW INSTEAD OF THE BROKEN FIRST USE SCREW INTO ANOTHER HOLE, THE SECOND USE SCREW WAS ALSO BROKEN. BOTH THE TWO SCREWS REMAINED IN THE BONE. THE REMOVING OPERATION WILL NOT CARRY ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WUBU MINI SCREWS, C-F, S-T, 1.7X6 IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR