BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER NATURAL NAIL SYSTEM CANCELLOUS SCREW

    MDR report key: 2082880 · Received May 3, 2011

    Report

    Report Number
    1822565-2011-01058
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    February 24, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS REC'D FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: IT IS UNK HOW THIS SCREW WAS INSERTED IN THE NAIL DURING THE SURGERY. IF THE SCREW IS NOT FULLY SEATED IN THE RETROGRADE NAIL, THE SCREW COULD BACK OUT FOLLOWING SURGERY. ALSO, ONE OF THE POSSIBLE REASONS FOR A SCREW BACKING OUT MAY BE DUE TO BUT NOT LIMITED TO THE PT POST-OP ACTIVITIES, SURGICAL TECHNIQUE ETC. NO X-RAYS WERE RETURNED. DETAILS OF SURGICAL TECHNIQUE USED ARE UNK. THERE IS INSUFFICIENT INFO PROVIDED TO DETERMINE THE ROOT CAUSE OF THIS INCIDENT. EVAL: THE FLUTES ON TIP OF SCREW EXHIBIT GOUGING. THE PART IS CONFORMING WHERE MEASURED. THREAD FORM, RUN OUT, AND MAJOR/MINOR DIAMETERS WERE CHECKED ON COMPARATOR WITH OVERLAY AND FOUND TO BE CONFORMING. THE MFG RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING INDICATING THAT THE DEVICES WERE MFR, INSPECTED, AND PACKAGED TO SPECIFICATION. CAUSE CANNOT BE DEFINITIVELY DETERMINED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED BECAUSE THE MOST DISTAL TRANSVERSE SCREW HAD BACKED OUT FROM (B)(4) RETROGRADE NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER NATURAL NAIL SYSTEM CANCELLOUS SCREW HSB ZIMMER, INC. 61236381

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention