BEUDAMED
    FDA Adverse Event Other Summary report: N

    BONE SCREWS, CROSS-PIN, MP, SELF-DRILLING, 2,0X4MM

    MDR report key: 1884827 · Received October 25, 2010

    Report

    Report Number
    8010177-2010-00384
    Event Type
    Other
    Date Received
    October 25, 2010
    Date of Event
    August 2, 2010
    Report Date
    September 14, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE PREVIOUS CASES REGARDING THE BLADE: THE COURSE OF THE DAMAGES POINTED TO THE FACT THAT THE INSERTION OF THE BLADES INTO THE SCREW HEADS WERE NOT DEEP ENOUGH AND THEREFORE, A CORRECT CONNECTION WERE NOT ACHIEVED. SUBSEQUENTLY THE BLADES SLIPPED OUT OF THE SCREW HEADS DURING THE APPLICATION AND CAUSED THE OCCURRED DAMAGES ON THE WINGS OF THE BLADES. IN THE INSTRUCTION FOR USE (IFU) IT IS RECOMMENDED THAT: "WHEN LOADING THE SCREW, ALIGN THE CROSS-PIN SCREWDRIVER BLADE TO THE CROSS-PIN SCREW HEAD. KEEP THE SCREWDRIVER PERPENDICULAR TO THE SCREW HEAD AND APPLY SOME MODERATE DOWNWARD PRESSURE, AN AUDIBLE "CLICK" SHOULD BE HEARD." BASED ON STATISTICAL EVAL NO INDICATION WAS FOUND FOR ANY DEVICE RELATED ISSUE. POSSIBLE ROOT CAUSES (ACCORDING TO THE DESIGN RISK ANALYSIS) ARE: FATIGUE OVER LIFETIME (E.G. DEFORMATION, ETC.), ARTICLES NOT INTENDED FOR THIS PROCEDURE ARE USED (ARTICLES FROM OTHER MANUFACTURERS OR ARTICLES FROM OTHER STRYKER SYSTEMS), INCORRECT USER HANDLING (NO AXIAL ALIGNMENT, BLADE WAS NOT ENTERED DEEP ENOUGH IN THE SCREW HEAD). DEFORMATION OF SCREW DUE TO MULTIPLE PICK-UPS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CMF SALES REP OF STRYKER (B)(6), THAT THE FOLLOWING ALLEGED EVENT OCCURRED: "DURING THE SURGERY THAT TOOK PLACE ON 2ND AUGUST, WHEN THE SURGEON INSERTED THE SCREWDRIVER IN THE SCREWS HEAD IN ORDER TO TIGHTEN, THE SCREWDRIVER BLADE JUMPED/DID NOT JAM. THIS DAMAGED THE SCREWS HEAD CONSEQUENTLY." IT WAS FURTHER REPORTED THAT THE SCREWS ARE NOT AVAILABLE FOR INVESTIGATION AS THEY ARE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE SCREWS, CROSS-PIN, MP, SELF-DRILLING, 2,0X4MM IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK