BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.5MM MEDULLARY REAMER HEAD

    MDR report key: 3082094 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-02032
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. AS INDICATED IN THE DHR THE CORRECT MATERIAL, 1.4112, WAS USED AND HARDNESS WAS WITH HV 699 WITHIN THE SPECIFICATION OF HV 690 +, -40. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. THE RELEVANT DIMENSIONS WERE CHECKED AND NO DEVIATION WAS FOUND. NO MANUFACTURING RELATED FAULT COULD BE DETECTED. IT IS CLEARLY VISIBLE THAT THE CUTTING EDGES OF THE REAMER ARE COMPLETELY BLUNT. THIS LET US ASSUME THAT A MECHANICAL OVERLOAD BY THE USE OF A BLUNT INSTRUMENT CAUSED THIS BREAKAGE. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED AND THE INVESTIGATION IS ONGOING. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT HAD A MID SHAFT TIBIA FRACTURE. THE SURGEON WAS DOING A TIBIAL RODING PROCEDURE WHEN THE 8.5MM FRONT CUTTING REAMER HEAD BROKE INTO THREE PIECES INSIDE THE PATIENT. THE SURGEON RETRIEVED ALL THREE BROKEN PIECES AND THE MAIN BODY OF THE REAMER IS INTACT. THE SURGEON FELT CONFIDENT NOTHING LEFT IN THE PATIENT. THE SURGERY WAS DELAYED BY 10-15 MINUTES DUE TO THIS INCIDENT. THERE WAS NO PATIENT HARM NOTED AND THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH A ZIMMER REAMER. THIS IS 1 OF 1 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183844 8.5MM MEDULLARY REAMER HEAD HTO SYNTHES GMBH 23944

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR