BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREWS,CROSS-PIN,2.7X16MM,1/P

    MDR report key: 4230616 · Received November 6, 2014

    Report

    Report Number
    0008010177-2014-00319
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    KTT
    PMA / PMN Number
    K113327
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRIMARY DISTAL RADIUS FRACTURE SURGERY, THE HEAD OF THE 2.7 BONE SCREW WAS BROKEN. THE PIECE WAS LEFT IN THE PATIENT. THERE WAS A 15 MINUTE DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715217 BONE SCREWS,CROSS-PIN,2.7X16MM,1/P APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT STRYKER LEIBINGER FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other