BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL

    MDR report key: 2883514 · Received December 21, 2012

    Report

    Report Number
    2520274-2012-04286
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 23, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A HUMERAL NAIL PROCEDURE, THE SURGEON COMPLAINED THAT THE SURGICAL TECHNIQUE GUIDE WAS INADEQUATE IN THE DESCRIPTION OF HOW TO DETERMINE THE ENTRY POINT FOR A RETROGRADE APPROACH WITH THE HUMERAL NAIL. THE SURGEON USED AN INCORRECT ENTRY POINT AND SUBSEQUENTLY LED TO AN IATROGENIC FRACTURE. THE SURGEON SUGGESTED THE SURGICAL TECHNIQUE GUIDE SHOULD PROVIDE PRECISE MEASUREMENTS IN CM OR MM WHERE THE ENTRY POINT IS IN RELATION TO THE SURROUNDING ANATOMICAL LANDMARKS. THE SURGEON COMPLAINED THAT THE ROUTER AND BURR FOR MAKING THE OPENING IN THE BONE WERE FUNCTIONALLY POOR IN WHAT THEY HAVE BEEN DESIGNED TO DO. THE SURGEON ALSO REPORTED THAT THE DEPTH GAUGE WAS INEFFECTIVE AND CAUSING HIM TO INSERT A SCREW THAT WAS TOO SHORT PROXIMALLY. THE SCREW WAS REPLACED WITH ANOTHER SCREW. THE PROCEDURE TOOK FOUR HOURS. REPORTEDLY THE SURGEON HAS NEVER DONE A RETROGRADE HUMERAL NAILING PROCEDURE PRIOR TO THIS PROCEDURE. THIS IS 4 OF 4 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAIL JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention DEPTH GAUGE, ROUTER/BURR, SCREW