BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM CANNULATED DRILL BIT/QC 150MM

    MDR report key: 4245711 · Received November 12, 2014

    Report

    Report Number
    1719045-2014-10582
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 17, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    PMA / PMN Number
    PK012945
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND REPORTED AVALIGN TECHNOLOGIES-NEMCOMED MANUFACTURED THE 2MM CANNULATED DRILL BIT, PART #310.221, AND LOT #7033701 ON PO #1421750 FOR 223 PIECES DATED DECEMBER 10, 2012. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED DECEMBER 5, 2012 AND TO THE SYNTHES FINAL INSPECTION SHEET #NS059354, REVISION ¿B¿. THE PARTS WERE RELEASED TO THE WAREHOUSE ON DECEMBER 14, 2012. THERE WERE NO MATERIAL REVIEW REPORTS, NONCONFORMANCE REPORTS OR COMPLAINT RELATED ISSUES WITH THIS LOT. THE 2MM CANNULATED DRILL BIT WAS MADE TO THE SYNTHES DRAWING P/N 310.221, REVISION ¿E¿, RELEASED ON 8/28/2012. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 DURING A SURGICAL PROCEDURE OF THE HAND/WRIST THE 2.0MM CANNULATED DRILL/QC 150MM BROKE OFF. A 30 MINUTE DELAY REPORTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AN IMAGE READING OF THE X-RAYS WAS CONDUCTED BY A MEDICAL DIRECTOR FROM THIS MANUFACTURER AND REPORTED THE FOLLOWING: I HAVE REVIEWED THE COMPLAINT DESCRIPTION AND THE ACCOMPANYING XRAY. I CANNOT CONFIRM THAT A DRILL BIT BROKE BECAUSE I CANNOT SEE THAT IN THE IMAGE PROVIDED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728225 2.0MM CANNULATED DRILL BIT/QC 150MM BIT,DRILL HTW SYNTHES MONUMENT 7033701

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR