BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM DRILL BIT/MQC FOR THREADED HOLE/74MM

    MDR report key: 7487566 · Received May 4, 2018

    Report

    Report Number
    8030965-2018-53539
    Event Type
    Malfunction
    Date Received
    May 4, 2018
    Date of Event
    April 12, 2018
    Report Date
    April 16, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTW
    UDI-DI
    07612334091420
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PART 03.130.302S, LOT L478373: MANUFACTURING SITE: SELZACH. SUPPLIER: FRUEH VERPACKUNGSTECHNIK AG. RELEASE TO WAREHOUSE DATE: JULY 05, 2017. EXPIRY DATE: JUNE 01, 2027. DEVICE WAS FIRST MANUFACTURED UNSTERILE UNDER THE LOT F-22274 BY THE SUPPLIER SPHINX WERKZEUGE AG AND STERILIZED AFTERWARDS. NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    PATIENT INFORMATION IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY TWO DRILL BITS BROKE. THE SURGEON WAS USING THE VARIABLE ANGLE (VA) HAND SYSTEM. HE USED A 1.5MM DRILL BIT AND THIS BROKE ONCE HE STARTED DRILLING. THE SURGEON WAS ABLE TO RETRIEVE ALL THE FRAGMENTS. HE THEN PROCEEDED TO USE ANOTHER 1.5MM DRILL BIT; THIS BROKE ALSO AND BUT HE WAS UNABLE TO RETRIEVE SOME OF THE DRILL BIT WHICH HAS BEEN LEFT IN THE PATIENT. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329679 1.5MM DRILL BIT/MQC FOR THREADED HOLE/74MM BIT, DRILL HTW OBERDORF SYNTHES PRODUKTIONS GMBH L478373 07612334091420

    Patients

    Seq Age Sex Outcome Treatment
    1