BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE

    MDR report key: 3500973 · Received December 5, 2013

    Report

    Report Number
    8030965-2013-05381
    Event Type
    Malfunction
    Date Received
    December 5, 2013
    Date of Event
    November 8, 2013
    Report Date
    November 8, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: HSZ, GFA, GFF. (B)(4). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. THE DEVICE HISTORY RECORDS REPORT STATES THAT THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING SURGERY ON (B)(6) 2013, THE DRILLBIT 2.0 BROKE OFF INTO PIECES WHILE DRILLING OVER THE K-WIRE. THE PIECES HAD TO BE REMOVED OUT OF THE PATIENT, BUT STILL SOME PIECES ARE IN THE PATIENT. ACCORDING TO THE SURGEON THE SURGERY WILL BE PROLONGED BY 20 MINUTES AS THE DEBRIS HAS TO BE REMOVED FROM THE BONE AND TISSUE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631200 DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE HWE SYNTHES GMBH F-13996

    Patients

    Seq Age Sex Outcome Treatment
    1