BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACETABULAR UNIVERSAL FIXED ANGLE DRIVER

    MDR report key: 2093261 · Received May 3, 2011

    Report

    Report Number
    1822565-2011-01091
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 7, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COLLET WAS NOT RETURNED. A PORTION OF THE THREADED TIP, WHICH IS NORMALLY PROTECTED BY THE COLLET, IS FRACTURED OFF. THE THREADS EXHIBIT DAMAGE. THE RING AROUND THE THREADED PORTION HAS BEEN DEFORMED BY CONTACT WITH ANOTHER PART. SURGICAL NOTES WERE NO PROVIDED. IT IS NOT KNOWN HOW THE DRIVER WAS BEING USED AT THE TIME OF THE EVENT. IT IS NOT KNOWN IF THE INSTRUMENT WAS IN CONTACT WITH HARD BONE OR SOME OTHER METALLIC DEVICE. THE DRILL BIT USED WAS NOT RETURNED. NOTHING IS KNOWN ABOUT ITS CONDITION. THE DEVICE HAD A POTENTIAL FIELD AGE OF 10.5 YEARS. ITS USAGE HISTORY OVER THAT TIMEFRAME IS NOT KNOWN. THE DAMAGE NOTED IN THIS COMPLAINT MAY BE DUE TO (BUT NOT LIMITED TO): EXCESSIVE FORCE THAT MAY HAVE APPLIED DURING USAGE, CONTINUED OPERATION AFTER IT WAS STUCK AGAINST HARD MATERIAL, RAPID FORWARD AND REVERSAL OF DIRECTION OF ROTATION WHEN THE DEVICE IS STUCK, EXCESSIVE BENDING AROUND CORNERS, DEVICE WEAR DUE TO USAGE WITH TIME, LOW SPEED/HIGH TORQUE OF OPERATION. HOWEVER, A ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DRILL BROKE WHILE DRILLING SCREW HOLES IN THE ACETABULUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACETABULAR UNIVERSAL FIXED ANGLE DRIVER HIP INSTRUMENT HXX ZIMMER INC 1450298

    Patients

    Seq Age Sex Outcome Treatment
    1