BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERAL GUIDE WIRE

    MDR report key: 1930227 · Received November 23, 2010

    Report

    Report Number
    1822565-2010-01176
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 21, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HXI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A USER FACILITY WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: NO INFO (I.E. POST-OP X-RAYS) WAS PROVIDED WITH THE COMPLAINT REGARDING HOW THE WIRE WAS IMPLANTED AND THE TYPE OF LOADING THIS INSTRUMENT WAS SUBJECTED TO DURING SURGERY. IF THE WIRE WAS EXCESSIVELY BENT OR LOADED DURING SURGERY, THE WIRE COULD HAVE BROKEN AS A RESULT. A COMPLAINT HISTORY PERFORMED FOR A 12-MOTH PERIOD (B)(6) 2009 - (B)(6) 2010 FOUND NO PREVIOUSLY REPORTED COMPLAINTS. EVAL CODES: 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 INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHILE DOING RIGHT TIBIA INTERMEDULLARY RODDING, THE GUIDE WIRE BENT AND BROKE WHILE INSERTING THE NAIL. IT WAS NECESSARY TO MAKE A SMALL INCISION OVER THE FRACTURE SITE TO EXTRACT THE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMERAL GUIDE WIRE TRAUMA INSTRUMENT HXI ZIMMER, INC. 61426296

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention