BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUTTING EDGE ADV RASP HANDLE

    MDR report key: 1894851 · Received November 5, 2010

    Report

    Report Number
    2249697-2010-01472
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 12, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT #PYA60, MANUFACTURE DATE: 07/01/04. SUMMARY OF EVALUATION: VISUAL INSPECTION OF THE TWO STRAIGHT CEA RASP HANDLES CONFIRMED THE EVENT. ONE RASP HANDLE EXHIBITED A CRACK IN THE HANDLE BODY INFERIOR TO THE STRIKE PLATE, THOUGH THE STRIKE PLATE REMAINED ATTACHED. THE SECOND HANDLE EXHIBITED A SIMILAR FRACTURE WHICH HAD FULLY PROPAGATED, ALLOWING THE STRIKE PLATE TO DISASSOCIATE FROM THE HANDLE BODY. THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE WAS DESIGNED RELATED, ALTHOUGH IMPACTION MARKS ON EACH PROXIMAL BODY INDICATED A MALLET WAS INCORRECTLY USED TO EXTRACT THE RASP FROM THE FEMUR. IT HAS BEEN DEMONSTRATED THAT THIS WILL ACCELERATE THE FRACTURE CONDITION AND EFFECTIVELY REDUCE THE OVERALL STRENGTH OF THE RASP HANDLE. A DESIGN CHANGE WAS IMPLEMENTED TO STRENGTHEN THE AREA BETWEEN THE STRIKE PLATE AND HANDLE. HOWEVER, THE DEVICE REPORTED IN THIS EVENT WAS MANUFACTURED PRIOR TO COMPLETION OF THIS CHANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "HEAD ON THE TOP OF BOTH BROACH IMPACTORS BROKE OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUTTING EDGE ADV RASP HANDLE INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA PYKJB

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention