BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE

    MDR report key: 2945265 · Received February 6, 2013

    Report

    Report Number
    2520274-2013-00800
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    October 13, 2012
    Report Date
    October 15, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    PMA / PMN Number
    K962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW REPORTED, MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INTERNAL INVESTIGATION BY SYNTHES (B)(4) REPORTS: THE MEASURABLE DIMENSION WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. 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 AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING AN OPERATION TO FIXATE LOOSE BONE FRAGMENT ON THE NAVICULAR BONE THE SURGEON POSITIONED THE WIRE AFTER REDUCTION AND ATTEMPTED TO DRILL THE CORTEX, DURING THIS ATTEMPT THE DRILL TIP BROKE OFF. A DIFFERENT WIRE WAS POSITIONED AND THE SECOND DRILL BIT TIP BROKE OFF. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49829 DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE DRILL BIT HTW SYNTHES GMBH F-11332

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR