BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYAXIAL SCREW DRIVER 8.0+

    MDR report key: 3871273 · Received April 15, 2014

    Report

    Report Number
    2032593-2014-00017
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 21, 2014
    Manufacturer
    SEASPINE, INC.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THIS IS THE SECOND REPORT OF TWO REPORTS CONCERNING THE SAME PT SURGERY. THIS REPORT CONCERNS A MALIBU SCREW DRIVER 8.0+. LOT # AH32537D (SEE MFG REPORT NUMBER # 2032593-2014-00016). IT WAS REPORTED DURING A L4-ILIUM POSTERIOR FUSION, THE SURGEON HAD ISSUES WITH TWO 8.0 MALIBU DRIVERS (91-2109). WHILE THE SURGEON INSERTED THE ILIAC SCREWS IT WAS UNCLEAR AS TO WHETHER THE DRIVER TIPS SHEARED OFF, OR THE TIPS STRIPPED, BUT ONE OF THOSE FAILURE MODES CAUSED BOTH DRIVERS TO NO LONGER FUNCTION CORRECTLY. THE SURGEON REMOVED THE FIRST DRIVER AFTER IT FAILED AND USED THE SECOND DRIVER WHICH ALSO FAILED. THE SYSTEM ONLY CONTAINS TWO DRIVERS AND THERE WAS NOT ANOTHER CLEAN, STERILIZED DRIVER AVAILABLE FOR THE CASE. THIS RESULTED IN A TOTAL DELAY OF APPROXIMATELY 5 MINUTES AND CAUSED THE SURGEON TO HAVE TO LEAVE THE SCREW HEAD A LITTLE MORE PROUD (LESS THAN 1MM) THAN HE WOULD NORMALLY PREFER. THERE WAS NO REPORTED INJURY OR ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230682 POLYAXIAL SCREW DRIVER 8.0+ MALIBU KWQ SEASPINE, INC. AH32537D

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR