BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREWS, CROSS-PIN, DIAM.2.0X14MM, (5/PACKAGE)

    MDR report key: 4735678 · Received April 29, 2015

    Report

    Report Number
    0008010177-2015-00090
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Date of Event
    April 21, 2015
    Report Date
    April 21, 2015
    Manufacturer
    STRYKER LEIBINGER-FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    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. THE BLADE (ARTICLE # 62-20130) AND THE DRILL (ARTICLE # 60-16526) USED FOR THIS CASE WERE FURTHER PROVIDED. THEY ARE PART OF THE SYSTEM AND CAN BE USED FOR THE COMPLAINED SCREW. A REVIEW OF THE DESIGN RISK ANALYSIS, REVEALED THE FOLLOWING FURTHER, POSSIBLE ROOT CAUSES: INCORRECTLY SELECTED IMPLANTS, INCORRECTLY SELECTED/ ASSEMBLED IMPLANT/ INSTRUMENT, INSUFFICIENT/TOO HIGH BONE QUALITY, WRONG/ MISSING INFORMATION, REUSE OF SINGLE-USE DEVICES, IMPLANT/INSTRUMENT MIX-UP, WRONG/ MISSING FUNCTIONALITY CHECK, IMPROPER IMPLANT PLACEMENT (E.G. ARCH BAR, SCREW...), TOO MUCH/ WRONG FORCES BETWEEN BLADE, SCREW AND BONE (E.G. SCREW HEAD DEFORMATION, SCREW BREAKAGE), POWER TOOL USAGE FOR SCREW INSERTION (NOT QDM), 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.

    Description of Event or Problem · 1

    THE HEAD OF A SCREW (PART # 50-20414) BROKE OFF DURING SURGERY. THE SHAFT OF THE SCREW IS STILL IN THE MANDIBLE OF THE PATIENT. THE SURGERY IS COMPLETE AND THERE WERE NO ADVERSE AFFECTS TO THE PATIENT. THE PART WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    THE HEAD OF A SCREW (PART # 50-20414) BROKE OFF DURING SURGERY. THE SHAFT OF THE SCREW IS STILL IN THE MANDIBLE OF THE PATIENT. THE SURGERY IS COMPLETE AND THERE WERE NO ADVERSE AFFECTS TO THE PATIENT. THE PART WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281694 BONE SCREWS, CROSS-PIN, DIAM.2.0X14MM, (5/PACKAGE) IMPLANT JEY STRYKER LEIBINGER-FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1