BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM

    MDR report key: 3964806 · Received July 29, 2014

    Report

    Report Number
    3000270450-2014-10053
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HTW
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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

    IT WAS REPORTED THAT THE SURGEON WAS DRILLING WITH A 2.0 DRILL IN A VA LCP POSTEROLATERAL DISTAL HUMERUS PLATE WHEN THE TIP OF THE DRILL BIT BROKE. SURGEON SEARCHED FOR THE DRILL BIT TIP AND TOOK X-RAYS BUT WAS UNABLE TO FIND THE BROKEN TIP. IT WAS DETERMINED BY THE SURGEON THAT THE DRILL BIT TIP WAS STILL IN THE PATIENT AND HE DECIDED TO CONTINUE ON WITH THE SURGERY. THE SURGERY WAS COMPLETED WITHOUT DELAY. THERE WAS A DELAY BUT IT WAS NO MORE THAN TWO MINUTES. THE PATIENT WAS NOT HARMED DURING PROCEDURE. THERE WAS ANOTHER DRILL BIT AVAILABLE TO COMPLETE THE SURGERY. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441735 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM BIT,DRILL HTW SYNTHES SELZACH F-10360

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention