BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø4.3 L280 F/324.007

    MDR report key: 2920376 · Received January 17, 2013

    Report

    Report Number
    8030965-2013-00158
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 13, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE COMPLETE SPIRAL GROOVED TIP OF THE DRILL BIT IS BROKEN OFF AND MISSING. THE MEASURABLE DIMENSION OF THE BROKEN DRILL BIT WAS CHECKED AND FOUND TO BE IN COMPLIANCE WITH (B)(4). THE EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH (B)(4). THE FRACTURED SURFACE IS HOMOGENEOUS AND SHOWS THE TYPICAL VIEW OF A FORCED RUPTURE. THE MICROSCOPIC VIEW OF THE BROKEN SURFACE DOES NOT SHOW ANY ANOMALIES OF MATERIALS STRUCTURE WHICH INDICATES MATERIAL CONFORMITY AS WELL. WE ASSUME THAT THE TIP BROKE OFF DURING A MECHANICAL OVERLOADING SITUATION. VARIOUS CIRCUMSTANCES MAY LED TO THE BREAKAGE SUCH AS EXPOSING TO EXTENDED LATERAL STRESS, CONTACT WITH OTHER METALLIC PARTS OR BLUNT CUTTING EDGES. THIS DEVICE WAS MANUFACTURED AND DISTRIBUTED IN MID 2007, THE CONDITION OF THE CUTTING BLADES BEFORE SURGERY IS UNKNOWN. MANUFACTURING AND INSPECTION RECORDS INDICATE NO PROBLEMS WITH THE LOT IN QUESTION. NO PRODUCT RELATED FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    HOSPITAL IN (B)(6) REPORTED THAT THE DRILL BIT BROKE WHILE SURGEON WAS DRILLING THE LEFT FEMUR CONDYLE. THE SURGEON DECIDED TO LEAVE THE 4.5CM TIP OF THE DRILL BIT IN THE PATIENT. THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26681 DRILL BIT Ø4.3 L280 F/324.007 DRILL BIT HTW SYNTHES GMBH 2285190

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR