BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER BLADE, T7, AO

    MDR report key: 2926467 · Received January 16, 2013

    Report

    Report Number
    8010177-2013-90015
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 14, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THE SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEM. VISUAL EXAMINATION SHOWED THAT ALL FLANKS OF THE TIP/TORX OF THE RETURNED SCREWDRIVER BLADE WERE HEAVILY, PLASTICALLY DEFORMED. THE DIRECTION OF THE PLASTIC DEFORMATIONS AT THE FLANKS, POINTS TO THE INFLUENCE OF TOO HIGH TORSIONAL FORCES DURING APPLICATION. FURTHERMORE, A METAL FRAGMENT AT ONE FLANK WAS BROKEN. PRESSURE MARKS WERE ALSO VISIBLE AT THE SLOT AREA OF THE BLADE INDICATING HIGH BENDING FORCES. THE ROOT CAUSE FOR THE REPORTED EVENT CAN BE ATTRIBUTED TO A USER RELATED ISSUE. NO INDICATIONS WERE FOUND FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED ISSUE.

    Description of Event or Problem · 1

    DURING INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE TIP OF THE SCREWDRIVER WAS DEFORMED. HOWEVER, DURING INCOMING INSPECTION AT THE INVESTIGATION SITE IT WAS DETERMINED THAT A SMALL METAL FRAGMENT WAS BROKEN AT THE TIP OF THE SCREWDRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24237 SCREWDRIVER BLADE, T7, AO INSTRUMENT HXX STRYKER OSTEOSYNTHESIS FREIBURG NA AC08-08/2012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK