BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ES2 POLYAXIAL SCREWDRIVER SHAFT

    MDR report key: 6269905 · Received January 23, 2017

    Report

    Report Number
    0009617544-2017-00022
    Event Type
    Malfunction
    Date Received
    January 23, 2017
    Date of Event
    December 21, 2016
    Report Date
    June 6, 2017
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG#: 48280311. LOT#: 140475. METHOD: VISUAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: NO RELEVANT MANUFACTURING ISSUES WERE IDENTIFIED. INSPECTION OF THE RETURNED DEVICE DID NOT REVEAL ANY IDENTIFIABLE DEBRIS OR RUST. CONCLUSION: BECAUSE THE REPORTED ISSUE WAS NOT OBSERVED IN-HOUSE, THE ISSUE COULD NOT BE FULLY INVESTIGATED AND A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT IS LIKELY THAT THE EXTENDED TIME BETWEEN USE AND CLEANING IDENTIFIED ABOVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY ANALYSED WHAT LOOKED LIKE DEBRIS ON KITS THAT HAD BEEN RETURNED FROM AN EXTERNAL STERILISATION PROVIDER AND FOUND BOTH DEBRIS AND RUST. FOLLOWING RE-PROCESSING THE CUSTOMER FOUND DEPBRIS ON THE KITS AND AFTER THEY REPEATED THE WASH AND CLEAN PROCESSES WITH ULTRASONIC PRE CLEAN, THE SETS STILL HAVE DEBRIS ON SOME INSTRUMENTS. THE ADVERSE INCIDENT RECORDED BY THE CUSTOMER INTERNALLY STATED THAT 'TRAYS OPENED FOR PATIENTS OPERATION. DEBRIS IN CANNULATED TAPS AND SCREW DRIVER HANDLE, THEREFORE KIT UNUSABLE. SO INSTRUMENT TRAY, TAPS AND AWL HAVE DEBRIS IN. THEN KIT 3 OPENED, DEBRIS IN AWL AND CANNULATED TAPS. NO OTHER KIT AVAILABLE IN HOSPITAL. THE FIXATION TRAY, HOLE IN KIT THROUGH ALL LAYERS AND DEBRIS THEREFORE CASE CANCELLED.'

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY ANALYSED WHAT LOOKED LIKE DEBRIS ON KITS THAT HAD BEEN RETURNED FROM AN EXTERNAL STERILISATION PROVIDER AND FOUND BOTH DEBRIS AND RUST. FOLLOWING RE-PROCESSING THE CUSTOMER FOUND DEBRIS ON THE KITS AND AFTER THEY REPEATED THE WASH AND CLEAN PROCESSES WITH ULTRASONIC PRE CLEAN, THE SETS STILL HAVE DEBRIS ON SOME INSTRUMENTS. THE ADVERSE INCIDENT RECORDED BY THE CUSTOMER INTERNALLY STATED THAT 'TRAYS OPENED FOR PATIENTS OPERATION. DEBRIS IN CANNULATED TAPS AND SCREW DRIVER HANDLE, THEREFORE KIT UNUSABLE. SO INSTRUMENT TRAY, TAPS AND AWL HAVE DEBRIS IN. THEN KIT 3 OPENED, DEBRIS IN AWL AND CANNULATED TAPS. NO OTHER KIT AVAILABLE IN HOSPITAL. THE FIXATION TRAY, HOLE IN KIT THROUGH ALL LAYERS AND DEBRIS THEREFORE CASE CANCELLED.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54313 ES2 POLYAXIAL SCREWDRIVER SHAFT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT. LXH STRYKER SPINE-FRANCE 140475

    Patients

    Seq Age Sex Outcome Treatment
    1