BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 4210201 · Received October 29, 2014

    Report

    Report Number
    1719045-2014-10548
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    PMA / PMN Number
    PK962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING DATE: DECEMBER 31, 2008. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT ORCHID UNIQUE MANUFACTURED THE 2.5MM DRILL BIT QC, P/N 310.25, AND LOT NUMBER US98817 ON PO #962235 FOR (B)(4) PARTS THAT WERE DELIVERED ON DECEMBER 19, 2008, AND ON PO #971457 FOR 3 BATCHES OF PARTS ((B)(4)) THAT WERE DECEMBER 19, 2008 AND FOR 1 BATCH OF PARTS ((B)(4) PIECES) DELIVERED ON DECEMBER 24, 2008. INITIALLY, THE FIVE GROUPS OF PARTS CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED DECEMBER 19, 2008, AND SYNTHES FINAL INSPECTION SHEET #389IN477, REVISION ¿E¿. THE PARTS WERE RELEASED TO THE WAREHOUSE ON DECEMBER 30, 2008 ((B)(4)PIECES) AND ON DECEMBER 31, 2008 ((B)(4)). THERE WERE NO MRR¿S, NCR¿S, OR COMPLAINT RELATED ISSUES WITH THIS LOT. THE 2.5MM DRILL BIT QC WAS MADE TO THE SYNTHES DRAWING P/N 310.25, REVISION ¿J¿, RELEASED ON MARCH 11, 2004. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 A 2.5MM DRILL BIT BROKE WHEN THE SURGEON WAS IMPLANTING THE SCREWS. ALL PARTS WERE RETRIEVED AND REMOVED FROM PATIENT. THERE WAS NO HARM TO THE PATIENT AND NO DELAY TO SURGERY. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692760 2.5MM DRILL BIT/QC/GOLD/110MM BIT, DRILL HTW SYNTHES MONUMENT US98817

    Patients

    Seq Age Sex Outcome Treatment
    1