BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAMER Ø11 F/FEM-NECKSCR L440 NO. 511.76

    MDR report key: 2863989 · Received December 10, 2012

    Report

    Report Number
    8030965-2012-01519
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 12, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS THE DEVICE IS ENTERING THE INVESTIGATION PROCESS.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD. THE CROSS SECTION OF THE BROKEN SURFACE IS HOMOGENOUS AND SHOWS NO IRREGULARITIES WHICH INDICATE MATERIAL CONFORMITY AS WELL. WE DO SUPPOSE THOUGH THAT THE BREAKAGE OF THE TIP WAS CAUSED DUE TO A HEAVY OVERLOADING SITUATION DURING USE. PLEASE NOTE THAT THIS INSTRUMENT IS SEVERAL YEAR IN USE SINCE (B)(4) 2005, CLEARLY VISIBLE WEAR AND TEAR TRACES. NOTE CONTACT WITH OTHER METALLIC PARTS LIKE IMPLANTS, WIRES CAUSE SUCH BREAKAGES AND HAVE TO BE AVOIDED. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTED A REAMER TIP BROKE DURING REAMING. AN 11MM REAMER FOR THE FEMORAL NECK SCREW WAS BEING USED OVER THE 2.8MM GUIDE WIRE. USING A HOOK THE MAJORITY OF THE FRAGMENT WAS RETRIEVED, HOWEVER, A SMALL FRAGMENT REMAINS IN THE PATIENT BUT WAS NOT VISIBLE ON FINAL X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REAMER Ø11 F/FEM-NECKSCR L440 NO. 511.76 REAMER Ø11 HTO SYNTHES GMBH 1325411

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR