BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.5MM MEDULLARY REAMER HEAD

    MDR report key: 2821264 · Received November 6, 2012

    Report

    Report Number
    2520274-2012-02942
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT#: THE REPORTED LOT NUMBER IS 180780123. THE LOT NUMBER PROVIDED IS NOT A VALID SYNTHES OR SUPPLIER LOT NUMBER. A REVIEW OF THE DEVICE HISTORY RECORDS CANNOT BE REVIEWED UNTIL THE LOT NUMBER IS VALIDATED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. OBTAINED FROM COMPLETED QUESTIONNAIRE RECEIVED. LOT NUMBER CHANGED PER THE DHR REVIEW. THE LOT NUMBER 180780123 DOES NOT EXIST AT SYNTHES (B)(4). BUT IT IS ASSUMED THAT 0123 IS NOT A PART OF THE LOT NUMBER AS THIS IS THE NUMBER OF OUR NOTIFIED BODY. BASED ON THIS ASSUMPTION THE ACTUAL LOT WOULD BE 18078 AND THIS NUMBER WAS USED FOR THIS PART. THE MANUFACTURING DOCUMENTS OF LOT 18078 WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8.5MM MEDULLARY REAMER HEAD 8.5MM MEDULLARY REAMER HEAD HTO SYNTHES USA 18078

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR