BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6715130 · Received July 14, 2017

    Report

    Report Number
    0008010177-2017-00168
    Event Type
    Malfunction
    Date Received
    July 14, 2017
    Date of Event
    June 19, 2017
    Report Date
    February 12, 2018
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K961496
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BECAUSE THE COMPLAINED SCREWS WERE NOT RETURNED A CONFIRMATION OF THE REPORTED EVENT WAS NOT APPLICABLE. ADDITIONAL INFORMATION REGARDING THE INVOLVED PLATE AND INSTRUMENTS WAS REQUESTED. THE USED PLATE REMAINED UNKNOWN. THE USED DRILL WAS CATALOG #60-16998 AND THE USED BLADE WAS CATALOG #62-20139. IT COULD BE DETERMINED THAT THESE INSTRUMENTS DO NOT BELONG TO THE UPPER-FACE SYSTEM OF THE COMPLAINED SCREW AND ARE THEREFORE NOT INTENDED TO BE USED WITH THE COMPLAINED SCREWS # 50-12904. AS A RESULT OF THE NOT CORRESPONDING INSTRUMENT-IMPLANT-COMBINATION RESPECTIVELY INSTRUMENT-IMPLANT-INTERFACES SCREW BREAKAGES ARE INEXPLICABLE AND APPEAR VERY UNLIKELY SINCE THE DRILLED HOLE WOULD BE WIDER THAN THE DIAMETER OF THE USED SCREW IN THIS INSTANCE. THEREFORE THE EXACT ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. ACCORDING TO THE RELATED RISK MANAGEMENT FILE, THE MOST LIKELY ROOT CAUSES COULD HAVE BEEN: UNSUFFICIENT/TOO HIGH BONE QUALITY. WRONG/ MISSING INFORMATION. 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. POWER TOOL USAGE FOR SCREW INSERTION (EXCEPT 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). POWERED SCREW INSERTION WITH RIGHT ANGLED SCREWDRIVER. BASED ON STATISTICAL EVALUATION THERE ARE NO INDICATIONS FOR ANY SYSTEMATIC DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE. THEREFORE NO CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME. THE COMPLAINT IS ADDED TO THE COMPLAINT TREND.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT SCREWS HEADS TWISTED OFF WHEN ATTEMPTING TO INSERT THEM INTO THE PLATE. THERE WAS NO SURGICAL DELAY, MEDICAL INTERVENTION, OR ADVERSE CONSEQUENCES REPORTED FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT SCREWS HEADS TWISTED OFF WHEN ATTEMPTING TO INSERT THEM INTO THE PLATE. THERE WAS NO SURGICAL DELAY, MEDICAL INTERVENTION, OR ADVERSE CONSEQUENCES REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494630 BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.2X4MM, UPPERFACE, (5/PACKAGE) IMPLANT HRS STRYKER LEIBINGER FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1