BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL LATERAL FIBULA PLATE, 3 HOLE

    MDR report key: 3092855 · Received May 3, 2013

    Report

    Report Number
    0008010177-2013-00083
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    KTT
    PMA / PMN Number
    K081284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INVESTIGATION REVEALED THAT FOUR LIPS OF THE PLATE HOLES SHOWED DEFORMATIONS. THE REPORTED EVENT COULD BE PARTIALLY CONFIRMED, BECAUSE ON SOME LIPS OF THE PLATE A PROPER LOCKING WAS ACHIEVED. THE PLATE HOLES WHERE A PROPER LOCKING WAS ACHIEVED WERE TURNED FURTHER. IT WAS ALSO SEEN THAT THE LIPS HAD A ROUNDED OUT APPEARANCE. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE FOR THE REPORTED EVENT CAN BE ATTRIBUTED TO TORSIONAL OVERLOADS. NO INDICATIONS WERE FOUND FOR ANY SYSTEMATIC, DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE.

    Additional Manufacturer Narrative · 1

    CURRENTLY THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. INTERNAL INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY IT WAS NOTICED THAT THREE LOCKING SCREWS WOULD NOT LOCK INTO THE PLATE. THE PLATE WAS LATER CHANGED AND AT THIS POINT ALL ORIGINAL SCREWS LOCKED INTO THE NEW 3 HOLE PLATE WITH NO ISSUES. THE CASE WAS THEN COMPLETED USING THE NEW PLATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY IT WAS NOTICED THAT THREE LOCKING SCREWS WOULD NOT LOCK INTO THE PLATE. THE PLATE WAS LATER CHANGED AND AT THIS POINT ALL ORIGINAL SCREWS LOCKED INTO THE NEW 3 HOLE PLATE WITH NO ISSUES. THE CASE WAS THEN COMPLETED USING THE NEW PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195071 DISTAL LATERAL FIBULA PLATE, 3 HOLE IMPLANT KTT STRYKER OSTEOSYNTHESIS-FREIBURG 1000079544

    Patients

    Seq Age Sex Outcome Treatment
    1