BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.2X4MM, UPPERFACE, (5/PACKAGE)

    MDR report key: 4799908 · Received May 27, 2015

    Report

    Report Number
    0008010177-2015-00113
    Event Type
    Malfunction
    Date Received
    May 27, 2015
    Date of Event
    May 5, 2015
    Report Date
    May 5, 2015
    Manufacturer
    STRYKER LEIBINGER-FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD NOT BE CONFIRMED BECAUSE THE COMPLAINED DEVICE WAS NOT RETURNED. CONSEQUENTLY, IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE WITHIN THIS INVESTIGATION. ACCORDING TO THE DESIGN RISK ANALYSIS, FOLLOWING POSSIBLE ROOT CAUSES WERE DEFINED: INCORRECTLY SELECTED/ ASSEMBLED IMPLANT/ INSTRUMENT. INSUFFICIENT/TOO HIGH BONE QUALITY. WRONG/ MISSING INFORMATION. REUSE OF SINGLE-USE DEVICES. TOO MUCH/ WRONG COMPRESSION/ TORSIONAL/ AXIAL FORCES. WRONG ROTATIONAL SPEED, UNINTENDED LOADS. BONE QUALITY RESULTING IN HIGH TORQUE. IMPROPER BLADE DISENGAGING. COLLISION WITH OTHER IMPLANT OR INSTRUMENT. PREDRILLED HOLE NOT DEEP ENOUGH (E.G. WRONG CHOICE OF INSTRUMENT/IMPLANT, SYSTEM MIXUP, POORLY ASSEMBLED/USED INSTRUMENT). BASED ON THE STATISTICAL EVALUATION THERE IS NO INDICATION FOR ANY SYSTEMATIC DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE. THE COMPLAINT IS ADDED TO THE COMPLAINT TREND. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE REPORTED THAT THE SURGEON WAS TIGHTENING A SCREW (50-12904) DOWN INTO A 4 HOLE PLATE (55-062540) AND THE SCREW BROKE IN THE SUPERIOR LATERAL ORBITAL RIM. THE SURGEON LEFT THE SHAFT OF THE SCREW IN THE PATIENT.

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE REPORTED THAT THE SURGEON WAS TIGHTENING A SCREW (50-12904) DOWN INTO A 4 HOLE PLATE (55-062540) AND THE SCREW BROKE IN THE SUPERIOR LATERAL ORBITAL RIM. THE SURGEON LEFT THE SHAFT OF THE SCREW IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342406 BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.2X4MM, UPPERFACE, (5/PACKAGE) IMPLANT JEY STRYKER LEIBINGER-FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1