BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITST FIXATION ONE-PIECE NAIL CAP

    MDR report key: 2081994 · Received April 5, 2011

    Report

    Report Number
    1822565-2011-00863
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 7, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE RETURNED DEVICE MEETS PRINT SPEC WHERE MEASURED. THE ISSUE MAY BE RELATED TO A USER ERROR, AS THERE ARE WITNESS MARKS ON THE NAIL CAP INDICATING THAT THE PART WAS NOT SCREWED IN PROPERLY AND MAY HAVE CROSS-THREADED. HOWEVER, THERE IS NOT ENOUGH INFO PROVIDED TO ESTABLISH A ROOT CAUSE. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. 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 ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON TRIED TO USE THE ITST SLIDING NAIL CAP 5MM, BUT SINCE HE COULDN'T INSTALL IT, THE SURGERY WAS COMPLETED WITH THE 0 MM SIZE CAP. SURGERY TIME WAS EXTENDED BY 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITST FIXATION ONE-PIECE NAIL CAP HSB ZIMMER, INC. 61084648

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR