BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDULLARY REAMER 6 L385

    MDR report key: 3083388 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10806
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    August 29, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K971544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE MEDULLARY REAMER WAS MANUFACTURED BY GREATBATCH MEDICAL. THE DEVICE WAS RECEIVED FOR A MANUFACTURING EVALUATION AND THE WELDING BETWEEN THE FLEXIBLE SHAFT AND THE REAMER BROKE DUE TO AN UNKNOWN CAUSE. THE HEADPIECE AND THE FLEXIBLE SHAFT CONFORMED TO SPECIFICATIONS. BASED ON THE EVALUATION PERFORMED AND THE UNKNOWN CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEAD BROKE OFF THE MEDULLARY REAMER WITHOUT AN APPLICATION ERROR. ALL PARTS WERE RETRIEVED. THIS REPORT IS FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183577 MEDULLARY REAMER 6 L385 HTO SYNTHES MONUMENT 6597171

    Patients

    Seq Age Sex Outcome Treatment
    1