BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION

    MDR report key: 4163502 · Received October 10, 2014

    Report

    Report Number
    2520274-2014-14085
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HTW
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE CONDUCTED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE LOT 7918878 DOES NOT MATCH TO ARTICLE (B)(4). LOT 7918878 DOES MATCH TO ARTICLE (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE WAS USED FOR A FRACTURE OF THE PROXIMAL HUMERUS IN COMBINATION USE WITH MULTILOC HUMERAL NAILING SYSTEM. THE SURGEON TOOK MUCH LONGER TIME FOR DRILLING AT THE DISTAL PART THAN USUAL DURING THE SURGERY BECAUSE THE TWO DRILL BITS WERE BLUNT. THERE WAS REPORTING OF A SURGICAL DELAY BUT EXACT TIME IS UNKNOWN THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639734 3.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION BIT, DRILL HTW SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1