BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREWS, CROSS-PIN, DIAM.2.0X12MM, (5/PACKAGE)

    MDR report key: 4490695 · Received February 6, 2015

    Report

    Report Number
    0008010177-2015-00020
    Event Type
    Malfunction
    Date Received
    February 6, 2015
    Date of Event
    January 15, 2015
    Report Date
    January 15, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. A PORTION OF THE DEVICE REMAINS IN THE PATIENT AND THE OTHER WAS DISCARDED BY THE HOSPITAL.

    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. ACCORDING TO THE EVENT DESCRIPTION THE SCREW WAS OVER-TORQUED WHEN INSERTING IT INTO THE BONE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, AS THE SURGEON WAS SCREWING P/N# 5020412 INTO THE PATIENT, THE SCREW WAS OVER-TORQUED AND THE "HEAD" OF THE SCREW SEPARATED COMPLETELY FROM THE REST OF THE SCREW. THE REMAINING BOTTOM HALF OF THE SCREW REMAINED IN PATIENT. NO FURTHER DELAY OR COMPLICATIONS IN PROCEDURE WERE REPORTED. THERE WERE NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, AS THE SURGEON WAS SCREWING P/N# 5020412 INTO THE PATIENT, THE SCREW WAS OVER-TORQUED AND THE "HEAD" OF THE SCREW SEPARATED COMPLETELY FROM THE REST OF THE SCREW. THE REMAINING BOTTOM HALF OF THE SCREW REMAINED IN PATIENT. NO FURTHER DELAY OR COMPLICATIONS IN PROCEDURE WERE REPORTED. THERE WERE NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86858 BONE SCREWS, CROSS-PIN, DIAM.2.0X12MM, (5/PACKAGE) IMPLANT JEY STRYKER LEIBINGER FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1