BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA 1.7X4MM SCREW, 10 EA

    MDR report key: 5886640 · Received August 18, 2016

    Report

    Report Number
    0008010177-2016-00191
    Event Type
    Injury
    Date Received
    August 18, 2016
    Date of Event
    July 26, 2016
    Report Date
    July 14, 2017
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    MAI
    PMA / PMN Number
    K993061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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. UNRELATED TO THE EVENT BEING REPORTED ON, DURING THE SURGERY THE PATIENT'S INTUBATION TUBE CAME OUT. ONCE THE INTUBATION TUBE WAS AGAIN SECURED, THE SURGEON CLOSED THE PATIENT WITHIN 10 MINUTES.

    Additional Manufacturer Narrative · 1

    THE COMPLAINED EVENT CANNOT BE CONFIRMED BECAUSE ALL COMBINATIONS WORKED AS INTENDED IN THE HANDLINGS/PICK-UP TESTS WITH ALL RETURNED SCREWS/BLADES THAT WERE TESTED. THE ISSUE WAS DISCUSSED WITH THE RELATED R&D DEPARTMENT. 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. FOR (B)(4) TWO CORRECTIONS WERE INITIATED. IN THE CORRECTION# (B)(4) AN IN-HOUSE PICK-UP TEST OF THE EXTERNAL SUPPLIER SCREWS WAS IMPLEMENTED AS AN INITIAL MEASURE. IN CORRECTION (B)(4) A MANUFACTURER CHANGE TO AN IN-HOUSE PRODUCTION AND THE MANUFACTURING PROCESS WAS IMPROVED AND THE WRENCH SIZE WAS ADJUSTED. FOR (B)(4) A CAPA (# (B)(4)) WAS INITIATED, WHICH REFERENCES THE CORRECTIONS THAT WERE ALREADY DEFINED FOR (B)(4). SINCE 2015-SEP-29 THE COMPLAINED DELTA SCREWS (70-17104, 70-17204 AND 70-17404) ARE MANUFACTURED IN-HOUSE BY STRYKER. THE CURRENTLY COMPLAINED SCREW UNITS WERE MANUFACTURED AFTER THE MANUFACTURER CHANGE WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT DURING A CRANIOSYNOSTOSIS THE ACCOUNT HAD DIFFICULTY LOADING AND RETAINING THE PRODUCT, WHICH CAUSED A DELAY OF 1.5-2.0 HOURS. INITIALLY, 6 SCREWDRIVERS WERE LOADED WITH SCREWS WITH NO ISSUES PRIOR TO THE CASE BEGINNING, BUT DURING THE LOADING PROCESS AFTERWARDS THE SCREWS WOULD EITHER NOT LOAD OR WOULD FALL OFF THE SCREWDRIVER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT DURING A CRANIOSYNOSTOSIS THE ACCOUNT HAD DIFFICULTY LOADING AND RETAINING THE PRODUCT, WHICH CAUSED A DELAY OF 1.5-2.0 HOURS. INITIALLY, 6 SCREWDRIVERS WERE LOADED WITH SCREWS WITH NO ISSUES PRIOR TO THE CASE BEGINNING, BUT DURING THE LOADING PROCESS AFTERWARDS THE SCREWS WOULD EITHER NOT LOAD OR WOULD FALL OFF THE SCREWDRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537181 DELTA 1.7X4MM SCREW, 10 EA IMPLANT MAI STRYKER LEIBINGER FREIBURG 2016050351

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO Other