BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA 1.7X4MM SCREW, 10 EA

    MDR report key: 5093884 · Received September 22, 2015

    Report

    Report Number
    0008010177-2015-00243
    Event Type
    Injury
    Date Received
    September 22, 2015
    Date of Event
    September 8, 2015
    Report Date
    September 8, 2015
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    MAI
    PMA / PMN Number
    K993061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE EVENT CAN BE CONFIRMED, BECAUSE IT IS A KNOWN ISSUE. A PREVIOUS COMPLAINT (B)(4) REGARDING THE SAME FAILURE MODE WAS INVESTIGATED AND CAN BE APPLIED TO THE CURRENT COMPLAINT: IT WAS NOT POSSIBLE TO PICK-UP 10 RETURNED SCREWS WITH A NEW SAMPLE BLADE (# 70-71770). IN THE VISUAL INSPECTION IT WAS FURTHER DETERMINED THAT THE SCREWS DO NOT SHOW ANY DAMAGES. THE RETURNED SCREWS WERE FORWARDED TO THE SUPPLIER (B)(4). THE SCREWS WERE MEASURED AND FOUND TO BE WITHIN THE SPECIFIED VALUES. THE ISSUE WAS DISCUSSED WITH THE RELATED R&D DEPARTMENT AND IT IS A KNOWN ISSUE THAT IN A WORST CASE COMBINATION OF THE SCREW AND THE BLADE THE SPECIFIED DIMENSIONS OF THE SCREW AND THE RELATED BLADES (70-71770, 70-92028, AND 70-92035) CAN SHOW A DIFFICULT PICK-UP ABILITY. THEREFORE THE COMPLAINT CAN BE ATTRIBUTED TO A DESIGN-RELATED ISSUE. (B)(4) HAD ALREADY BEEN OPENED FOR A PREVIOUS COMPLAINT (B)(4). BECAUSE FURTHER COMPLAINTS WITH DIFFERENT LOT NUMBERS WERE RECEIVED, (B)(4) WAS INITIATED. THIS NC RESULTED IN CAPA # (B)(4) TO PERFORM A DETAILED ROOT CAUSE ANALYSIS AND TO DETERMINE NECESSARY CORRECTIVE AND POTENTIAL PREVENTIVE ACTIONS. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY, THE SCREWS WOULD NOT LOAD ONTO THE SCREWDRIVE BLADE (PART# 7071770). MULTIPLE BOXES OF THE SAME LOT NUMBER WERE OPENED, BUT THE OR STAFF FOUND THE SAME PROBLEM WITH ALL OF THE SCREWS THEY TRIED. THEY ENDED UP HAVING TO USE THESE SCREWS BECAUSE THEY DIDN'T HAVE ANY OTHER LOTS AT THE FACILITY, BUT THEY HAD TO MANUALLY LOAD THEM AND HAD TO BE CAREFUL TO HOLD THEM ON THE SCREWDRIVER UNTIL THEY WERE INSERTED. THIS CAUSED A 30 MINUTE DELAY. THE COMPANY REPRESENTATIVE TRIED TO LOAD A DIFFERENT LOT ONTO THE SAME SCREWDRIVER BLADE LATER IN THE AFTERNOON AND THOSE SCREWS LOADED WITHOUT PROBLEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY, THE SCREWS WOULD NOT LOAD ONTO THE SCREWDRIVER BLADE (PART# 7071770). MULTIPLE BOXES OF THE SAME LOT NUMBER WERE OPENED, BUT THE O.R. STAFF FOUND THE SAME PROBLEM WITH ALL OF THE SCREWS THEY TRIED. THEY ENDED UP HAVING TO USE THESE SCREWS BECAUSE THEY DIDN'T HAVE ANY OTHER LOTS AT THE FACILITY, BUT THEY HAD TO MANUALLY LOAD THEM AND HAD TO BE CAREFUL TO HOLD THEM ON THE SCREWDRIVER UNTIL THEY WERE INSERTED. THIS CAUSED A 30 MINUTE DELAY. THE COMPANY REPRESENTATIVE TRIED TO LOAD A DIFFERENT LOT ONTO THE SAME SCREWDRIVER BLADE LATER IN THE AFTERNOON AND THOSE SCREWS LOADED WITHOUT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624133 DELTA 1.7X4MM SCREW, 10 EA IMPLANT MAI STRYKER LEIBINGER FREIBURG 2015040937

    Patients

    Seq Age Sex Outcome Treatment
    1 Other