BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø2 W/MARKING L110/85 2FLUTE

    MDR report key: 7098030 · Received December 7, 2017

    Report

    Report Number
    8030965-2017-50402
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    November 10, 2017
    Report Date
    November 10, 2017
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    GFG
    UDI-DI
    07611819158962
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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

    RELEASE TO WAREHOUSE DATE: OCTOBER 14, 2013. MANUFACTURING SITE: BETTLACH. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) 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 NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 FURTHER REPORTED THAT THE TIP OF THE DEVICE BROKE DURING USE. NO ADDITIONAL SURGICAL INTERVENTION REQUIRED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE 2.0MM DRILL BIT WITH DEPTH MARK BROKE DURING AN UNKNOWN PROCEDURE ON (B)(6) 2017. ALL FRAGMENTS WERE RETRIEVED. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876960 DRILL BIT Ø2 W/MARKING L110/85 2FLUTE BIT MILLING STERILE AND NON GFG OBERDORF : SYNTHES PRODUKTIONS GMBH 8666256 07611819158962

    Patients

    Seq Age Sex Outcome Treatment
    1