BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø2.5 L110/85 2FLUTE

    MDR report key: 2874602 · Received December 15, 2012

    Report

    Report Number
    8030965-2012-01590
    Event Type
    Malfunction
    Date Received
    December 15, 2012
    Date of Event
    October 19, 2012
    Report Date
    November 16, 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

    THIS DEVICE IS USED FOR TREATMENT 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. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LEAD TO THE BREAKAGE OF THE DRILL BIT. WE CAN ONLY ASSUME ACCORDING TO THE VISUAL DAMAGES ON THE SHAFT ITSELF THAT THE DRILL BIT GOT STUCK AND THE LATERAL FORCE MAY HAVE RESULTED IN THE BREAKAGE OF THE TIP. THE BROKEN SURFACE ITSELF IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY AS WELL. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT DURING A PROCEDURE FOR A TIBIAL FRACTURE, A PLATE WAS ALREADY IMPLANTED ON THE MEDIAL SIDE AND THE SURGEON WAS DRILLING LATERALLY. THE TIP OF THE DRILL BIT BROKE OFF AND THE BROKEN TIP WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL BIT Ø2.5 L110/85 2FLUTE DRILL BIT Ø2.5 L110/85 2FLUTE HTW SYNTHES GMBH 2807775

    Patients

    Seq Age Sex Outcome Treatment
    1