BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AO REAMING ATTACHMENT FOR TRAUMA RECON SYSTEM

    MDR report key: 3030534 · Received April 2, 2013

    Report

    Report Number
    2520274-2013-01737
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE DEVICE HISTORY RECORD REVIEW REPORTED THE FOLLOWING: MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW OF THE COMPLAINT, IT WAS DETERMINED THE COMPLAINT IS NOT REPORTABLE AS IT IS NOT LIKELY TO RESULT IN PATIENT HARM OR THE NEED FOR ADDITIONAL MEDICAL OR SURGICAL INTERVENTION. MANUFACTURING EVALUATION REVIEWED, MDR REPORTABILITY STATUS UPDATED PER PMRM AND FS-932. THIS DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT. SYNTHES IS RETRACTING MEDWATCH REPORT #2520274-2013-01737.NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE ON (B)(6) 2013 THE AO REAMING ATTACHMENT DID NOT MOVE WHEN TESTED. A SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. THIS IS 1 OF 1 REPORT FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133517 AO REAMING ATTACHMENT FOR TRAUMA RECON SYSTEM HWE SYNTHES USA 7324

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR