BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEXHEAD SCREWDRIVER WITH UNIVERSAL JOINT

    MDR report key: 2042184 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00560
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    April 12, 2010
    Report Date
    May 6, 2010
    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

    EVALUATION SUMMARY: THE PART WAS MANUFACTURED IN 1985, HAVING A POTENTIAL FIELD AGE OF 25 YEARS. LOOSENESS RESULTS FROM THE PRESENCE OF A U-JOINT WITHIN THE ASSEMBLY. THE U-JOINT DOES NOT APPEAR TO BE UNUSUALLY LOOSE. THE TIP OF THE SCREW-DRIVER IS A PERMANENTLY ATTACHED HEX DRIVER BIT WHICH IS CLEARLY WORN. THE MOST LIKELY ROOT CAUSE OF THE WEAR TO THE HEX BIT ON THE END OF THE SCREW DRIVER IS NORMAL USE OVER THE 25 YEAR LIFE OF THE INSTRUMENT. 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. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SCREWDRIVER IS STRIPPED AND LOOSE. SURGERY WAS PROLONGED BY 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEXHEAD SCREWDRIVER WITH UNIVERSAL JOINT HIP INSTRUMENT HXX ZIMMER INC 561021

    Patients

    Seq Age Sex Outcome Treatment
    1