BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAV STRAIGHT CUP POSITIONER

    MDR report key: 1961230 · Received December 21, 2010

    Report

    Report Number
    2249697-2010-01806
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 29, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    SCRUB TECH AT (B)(6) MENTIONED IT WAS HARD TO SCREW ON THE CUP. THEY CONTINUED WITH THE CASE, THE REP SAID IT DID NOT SLOW THEM DOWN AND NO ONE ELSE NOTICED IT. THE REP SAID IT FITS THE CUP AND TO CONTINUE SCREWING IT IN. THE TECH CONTINUED, THEY STILL IMPACTED THE CUP, GOT X-RAYS AND THE SURGEON LOVED THE PLACEMENT. WHEN THE REP LOOKED AT THE END OF THE IMPACTOR SHE NOTICED THERE WAS A PART WHERE THE THREADS WERE MISSING/MESSED UP. THE REP IS UNSURE IF THE SCRUB THREADED IT IN SURGERY OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAV STRAIGHT CUP POSITIONER INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention