BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER RATCHETING HANDLE, MANDIBULAR RECONSTRUCTION SYSTEM, 11.5CM

    MDR report key: 3140985 · Received June 3, 2013

    Report

    Report Number
    0008010177-2013-00104
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE HOSPITAL. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MACROSCOPIC INVESTIGATION OF THE RETURNED INSTRUMENT REVEALED THAT AT THE FRONT PART OF THE BLACK GRIP A FRAGMENT OF THE PLASTIC WAS BROKEN. WITHIN THE FUNCTIONAL TEST, A CORRECT FUNCTION OF THE RATCHETING MECHANISM SUCH AS A SMOOTH RUNNING SLIDER FOR ACTIVATING THE RATCHETING MECHANISM WAS DETERMINED. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE FOR THE REPORTED EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR WAS ALLEGEDLY PUSHING THE PLATE UP WITH THE HANDLE AND IT CRACKED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR WAS ALLEGEDLY PUSHING THE PLATE UP WITH THE HANDLE AND IT CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244179 SCREWDRIVER RATCHETING HANDLE, MANDIBULAR RECONSTRUCTION SYSTEM, 11.5CM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR