BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANTIS ROD INSERTER INNER SHAFT

    MDR report key: 2190940 · Received July 19, 2011

    Report

    Report Number
    9617544-2011-00248
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 22, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY ANALYSIS, MFG RECORD REVIEW, RISK REVIEW. RESULT: VISUAL INSPECTION COULD NOT BE PERFORMED AS PRODUCT WAS NOT RETURNED. COMPLAINT HISTORY ANALYSIS - (B)(4). INVESTIGATIONS ON PREVIOUS COMPLAINTS CONCLUDED RECURRENT ISSUES AND (B)(4) WAS INITIATED. THIS RECURRENT FAILURE IS ATTRIBUTABLE TO EXCESSIVE STRESS/TORQUE BEING APPLIED TO THE INSTRUMENT BY THE SURGEON DURING ROD INSERTION. MFG RECORD REVIEW - NO DEVIATIONS REPORTED. RISK REVIEW - SURGERY COULD HAVE TO BE CONVERTED TO OPEN SURGERY IF ANOTHER INSTRUMENT ISN'T READILY AVAILABLE OR IF SOME FRAGMENTS FROM BROKEN SHAFT WERE NOT EASILY RETRIEVABLE. CONCLUSION: THE PRODUCT IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVAL. HOWEVER, (B)(4) WAS INITIATED TO EVALUATE THE ROOT CAUSE OF THESE FAILURES BASED ON A PREVIOUSLY EXISTING TREND. AS A RESULT OF THIS CAPA, THE MANTIS ROD INSERTER INNER SHAFT AND MANTIS ROD INSERTER WERE REDESIGNED. A RECALL WAS INITIATED IN (B)(6) 2011 (REFER TO (B)(4)) FOR THIS PRODUCT ISSUE.

    Description of Event or Problem · 1

    DURING A SURGERY, NECK OF THE ROD INSERTER WAS BROKEN WHEN THE SURGEON TRIED TO INSERT THE ROD RIGHT AFTER HOLDING THE ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANTIS ROD INSERTER INNER SHAFT INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 09A436

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK