BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANTIS ROD INSERTER INNER SHAFT

    MDR report key: 2121773 · Received May 20, 2011

    Report

    Report Number
    9617544-2011-00179
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 25, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY REVIEW, MANUFACTURING RECORD REVIEW. RESULT: COMPLAINT HISTORY REVIEW - INVESTIGATIONS CONDUCTED ON PREVIOUS COMPLAINTS INDICATE THAT ROD INSERTION PROBLEMS ASSOCIATED WITH MANTIS ROD INSERTER INNER SHAFTS ARE RECURRENT. A CAPA HAD BEEN OPENED TO ADDRESS THE INSTRUMENT'S HIGH FAILURE RATES. MANUFACTURING RECORD REVIEW INDICATES THAT ALL RELEASED UNITS COMPLIED WITH APPEARANCE, SHAPE AND FUNCTIONAL SPECIFICATIONS. CONCLUSION: THE OBSERVED DEFECTS ON THE RETURNED MANTIS ROD INSERTER INNER SHAFT ARE RECURRENT FAILURES THAT ARE ATTRIBUTABLE TO EXCESSIVE STRESS/TORQUE BEING APPLIED TO THE INSTRUMENT BY THE SURGEON DURING ROD INSERTION. A CAPA WAS INITIATED TO EVALUATE THE ROOT CAUSE OF THESE FAILURES AND TO IMPLEMENT A CORRECTIVE AND PREVENTIVE ACTION PLAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE SURGEON INSERTED THE ROD PROPERLY, THE TIP OF THE ROD INSERTER WAS BROKEN WHEN THE SECOND ROD WAS INSERTED BETWEEN BLADES AND THE KNOB OF THE INSERTER WAS TIGHTENED BECAUSE, THE HOLDING OF THE ROD WAS WEAK. THE SURGEON DID NOT ADD TOO MUCH FORCE. SO, THE SURGEON HELD THE ROD WITH MAC HOLDER (HOSPITAL'S DEVICE) AND SET TO PROPER POSITION WITH BENT CHISEL ETC (HOSPITAL'S DEVICE). AFTER THAT THE OPERATION WAS CONTINUED AS USUAL. THERE WAS A 20 MINUTES DELAY IN THE PROCEDURE BECAUSE OF THE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANTIS ROD INSERTER INNER SHAFT INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 095793

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR