BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASEPLATE IMPACTOR EXTRACTOR

    MDR report key: 3781202 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01670
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K123486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT. VISUAL INSPECTION: THE DEVICE EXHIBITED NORMAL SIGNS OF WEAR AND TEAR WITH NO SIGNS OF ABUSE OR MISUSE. DIMENSIONAL INSPECTION: NOT PERFORMED AS THE FUNCTIONAL INSPECTION PROVED THE DEVICE TO BE FULLY FUNCTIONAL. FUNCTIONAL INSPECTION: AS THE MATING BASEPLATE WAS NOT RETURNED, ONE WAS PROCURED FROM FINISHED GOODS (CAT. NO 6541-4-805, LOT NO.: MKYRA) AND FUNCTIONALLY TESTED WITH THE IMPACTOR EXTRACTOR. THE DEVICE WAS FOUND TO SECURELY HOLD THE BASEPLATE AND THEREFORE WAS FULLY FUNCTIONAL. UPON LOCKING, THE LOCKING LEVER HAD ONLY TRAVELED ABOUT 3/4 OF ITS AVAILABLE DISTANCE LEAVING PLEANTY OF ROOM FOR ADITIONAL ADJUSTMENT IF IT HAD BEEN NEEDED. THE EVENT WAS NOT CONFIRMED. THE INVESTIGATION COULD NOT DETERMINE THE ROOT CAUSE OF THE EVENT AS FUNCTIONAL TESTING OF THE DEVICE FOUND IT TO BE FULLY FUNCTIONAL. THERE IS NO INDICATION AT THIS TIME THAT THE DESIGN, MATERIALS, OR MANUFACTURING OF THE SUBJECT DEVICE CONTRIBUTED TO THE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PRIMARY LEFT KNEE IMPLANTATION THE IMPACTOR WOULD NOT HOLD THE IMPLANT AND THE IMPLANT FELL ONTO THE FLOOR. A BACK UP INSTRUMENT AND DEVICE WERE IMMEDIATELY AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PRIMARY LEFT KNEE IMPLANTATION THE IMPACTOR WOULD NOT HOLD THE IMPLANT AND THE IMPLANT FELL ONTO THE FLOOR. A BACK UP INSTRUMENT AND DEVICE WERE IMMEDIATELY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260310 BASEPLATE IMPACTOR EXTRACTOR INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH N1C11

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other