BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE

    MDR report key: 3190896 · Received June 26, 2013

    Report

    Report Number
    8030965-2013-03720
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    February 21, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ADDITIONAL PRODUCT CODES: HSZ, GFA, GFF. (B)(6). A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE MEASURABLE DIMENSIONS OF THE DRILL BITS WERE AS FAR AS POSSIBLE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND SPECIFICATIONS. THE FRACTURE FACE OF THE DRILL BIT IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. NO PRODUCT FAULT COULD BE DETECTED. BASED ON THE PROVIDED DETAILS WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE. WE CAN ONLY ASSUME THAT AN UNDUE METALLIC CONTACT OR TOO MUCH LATERAL STRESS CAUSED THE BREAKAGE.

    Description of Event or Problem · 1

    DRILL BIT BROKE DURING SURGERY. THIS IS 1 OF 1 REPORT FOR EVENT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291534 DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE HWE SYNTHES GMBH F-11337

    Patients

    Seq Age Sex Outcome Treatment
    1