BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZNN CMN NAIL 13MMX21.5CM 130L

    MDR report key: 4924355 · Received July 16, 2015

    Report

    Report Number
    9613350-2015-00799
    Event Type
    Other
    Date Received
    July 16, 2015
    Date of Event
    July 4, 2015
    Report Date
    July 6, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS WERE MADE AVAILABLE. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO TREND WAS IDENTIFIED. THE COMPATIBILITY CHECK COULD NOT BE PERFORMED AS ONLY ONE PRODUCT WAS REPORTED TO US. THE PRODUCT COMPATIBILITY CHECK IS NOT RELEVANT FOR ONE PRODUCT ONLY. IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO INSERT THE DISTAL SCREW INTO THE NAIL WITH USING THE TARGETING GUIDE. FINALLY, THE SURGEON FREE HANDED THE DISTAL SCREW IN THE DYNAMIC HOLE. THE PRODUCTS WERE NOT RETURNED FOR INVESTIGATION (THE NAIL HAS BEEN IMPLANTED). NO OTHER SOURCE DOCUMENTS WERE PROVIDED. THE REVIEW OF THE INSPECTION PLAN SAP SHOWS THAT A VISUAL INSPECTION IS PERFORMED AT 100%. THE SURGICAL TECHNIQUE DESCRIBES THE CORRECT INSERTION OF THE DISTAL SCREW ON PAGE 10 AND 11. POSSIBLE CAUSES FOR THE REPORTED EVENT ACCORDING TO SAP DFMEA: IT WAS NOT POSSIBLE TO INSERT THE DISTAL SCREW INTO THE NAIL WITH USING THE TARGETING GUIDE DUE TO WRONG SURGICAL TECHNIQUE USED. IT WAS NOT POSSIBLE TO INSERT THE DISTAL SCREW INTO THE NAIL WITH USING THE TARGETING GUIDE DUE TO INSERTION OF THE NAIL IN THE WRONG DIRECTION (180° ROTATION). IT WAS NOT POSSIBLE TO INSERT THE DISTAL SCREW INTO THE NAIL WITH USING THE TARGETING GUIDE DUE TO INSERTION OF THE NAIL WITH THE WRONG CMN TARGETING GUIDE. IT WAS NOT POSSIBLE TO INSERT THE DISTAL SCREW INTO THE NAIL WITH USING THE TARGETING GUIDE DUE TO OFF-LABEL USE, E.G. MISUSE BY SURGEON. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICE, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW AS THE PATIENT HAS NOT BEEN REVISED. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY, THE PROBLEM OCCURRED WITH THE DISTAL STATIC SCREW MISSING THE NAIL POSTERIOR. IT WAS NOT POSSIBLE TO GET THE SLEEVES TO LINE UP WITH HOLE, SO THE SURGEON REMOVED THE NAIL TARGETING GUIDE AND FREE HANDED THE DISTAL SCREW IN THE DYNAMITING HOLE. THE SURGERY WAS DELAYED FOR 1HR 45 MINUTES, THE DEVICE HAS BEEN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463686 ZNN CMN NAIL 13MMX21.5CM 130L ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDU HSB ZIMMER GMBH NA 2635458

    Patients

    Seq Age Sex Outcome Treatment
    1 Other