BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.0MM FLEXIBLE MEDULLARY REAMER/FLAT WIRE/385MM

    MDR report key: 3021566 · Received March 26, 2013

    Report

    Report Number
    1719045-2013-10429
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    April 30, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K971544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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)

    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 DEVICE WAS RETURNED FOR A MANUFACTURING INVESTIGATION AND THE SHAFT EXHIBITED SLIGHT SCRATCHES ALONG THE SHAFT AND THE REAMER HAD MINOR MARKS ON THE CUTTING SURFACES. THE WELD BETWEEN THE FLEXIBLE SHAFT AND THE REAMER HEAD BROKE DUE TO AN UNKNOWN CAUSE. THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE REAMING THE BONE CANAL FOR A NAIL, THE REAMER HEAD BROKE. THE SURGEON DID NOT NOTICE THE REAMER HEAD WAS BROKEN UNTIL THE SURGEON PULLED THE REAMER SHAFT OUT OF THE HUMERUS. AFTER NOTICING THE BREAK, THE SURGEON REMOVED THE 2.5MM GUIDE ROD, REMOVED THE BROKEN REAMER HEAD, AND REINSERTED THE GUIDE ROD. THE SURGEON THEN USED ANOTHER REAMER TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124313 6.0MM FLEXIBLE MEDULLARY REAMER/FLAT WIRE/385MM HTO SYNTHES MONUMENT 6590713

    Patients

    Seq Age Sex Outcome Treatment
    1