BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND RASP

    MDR report key: 2095691 · Received April 27, 2011

    Report

    Report Number
    1822565-2011-01047
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 31, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT IS UNK HOW THE INSTRUMENT WAS BEING USED WHEN IT FRACTURED. IF THE RASP BECAME STUCK ON HARD BONE, EXCESSIVE FORCE MAY HAVE BEEN USED TO ADVANCE IT THROUGH THE BONE. THAT FORCE COULD LEAD TO FRACTURE. IN ADDITION, AN EXCESSIVE BENDING MOMENT ON THE RASP COULD HAVE CAUSED THE FRACTURE. BASED ON THE INFO PROVIDED, A DEFINITIVE CAUSE FOR THIS ISSUE CANNOT BE DETERMINED WITH CERTAINTY. THE RASP IS FRACTURED AT THE BASE OF THE CUTTING TEETH WHERE THE INSTRUMENT BEGINS TO CURVE. THE CUTTING TEETH STILL APPEAR TO BE SHARP. THE POTENTIAL FIELD AGE OF THE RASP IS APPROX 2 YEARS. THE DEVICE IS DIMENSIONALLY IN SPECIFICATION WHERE MEASURED, INCLUDING HARDNESS. DEVICE HISTORY RECORDS INDICATE THE COMPONENT WAS MANUFACTURED AND INSPECTED TO SPECIFICATION. NO MANUFACTURING ABNORMALITIES COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT FRACTURED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAND RASP LXH ZIMMER INC 61190559

    Patients

    Seq Age Sex Outcome Treatment
    1