BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA II PA SCREWDRIVER SHAFT

    MDR report key: 1937802 · Received December 2, 2010

    Report

    Report Number
    9617544-2010-00470
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 8, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY REVIEW. RESULT: COMPLAINT HISTORY REVIEW - SINCE 2004, 31 COMPLAINTS HAVE BEEN REPORTED ON THIS PRODUCT REFERENCE FOR A PRONG EITHER BENT OR BROKEN. CONCLUSION: SOME MARKS DUE TO THE WEAR OR DUE TO AN EXCESSIVE USE OF THIS INSTRUMENT ARE VISIBLE ON THE REMAINING PRONGS THAT SUGGEST THAT EXCESSIVE LOAD MAY HAVE BEEN APPLIED TO THE INSTRUMENT. IT IS UNCLEAR WHAT THE CONDITIONS OF THE INSTRUMENT OF USE WERE AND LOAD UNDER WHICH THE INSTRUMENT YIELDED SINCE ISSUE WAS DETECTED UPON PREPARATION PRIOR TO SURGERY. THE PRONG BREAKAGE OBSERVED ON THE RETURNED INSTRUMENT CAN BE THE RESULT OF VARIOUS FACTORS: AN OVERLOAD OR A BENDING LOAD APPLIED TO THE INSTRUMENT DURING LOADING IN THE PEDICLE DUE TO HARD BONE OR OMITTED STEPS PREPARING THE PATHWAY, RESULTING IN ADDITIONAL FORCE TO PROVIDE TO LOAD THE SCREW. PRONGS ARE DESIGNED SUFFICIENTLY LONG TO PROVIDE AN EFFICIENT AND RIGID CONNECTION TO THE SCREW IN ORDER TO DRIVE IT IN THE PEDICLE. HOWEVER, IF THE INSTRUMENT IS SUBJECTED TO A BENDING LOAD OR A LEVERAGE EFFECT, PRONG BREAKAGE CAN OCCUR.

    Description of Event or Problem · 1

    NURSE MRS. (B)(6) REPORTED, VIA SALES REP (B)(4), THAT DURING PREPARATION PRIOR TO A SURGERY, A CLEAT OF THE SHAFT BROKE OFF. NO FURTHER INFORMATION WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA II PA SCREWDRIVER SHAFT INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 077965

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK