BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø2.7 CALIBR L210/185 3FLUTE

    MDR report key: 4456145 · Received January 27, 2015

    Report

    Report Number
    9612488-2015-10076
    Event Type
    Malfunction
    Date Received
    January 27, 2015
    Date of Event
    January 12, 2015
    Report Date
    January 14, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. PMA 510(K): DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT NO NCRS 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. AS PER RECEIVED CONDITION OF DEVICE; THE TIP OF THE DRILL BIT IS BROKEN OFF. THE INVESTIGATION OF THE COMPLAINED ARTICLE SHOWS THAT THE TIP OF DRILL BIT IS BROKEN OFF. THE CUTTING EDGES HAVE SIGNS OF USE. THE EXACT CAUSE WHICH HAS LED TO THIS OCCURRENCE CANNOT BE DETERMINED. THERE WAS A HEAVY EXCEEDING MECHANICAL OVERLOADING SITUATION WHICH CAUSED THE BREAKAGE. THIS BLUNT DRILL BITS REQUIRE MORE MECHANICAL POWER DURING THE APPLICATION, BLUNT OR DAMAGED INSTRUMENTS NEED TO BE EXCHANGED BEFORE SURGERY. NO MANUFACTURING RELATED FAILURE COULD BE DETECTED. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A DRILL BIT IS BROKEN. PATIENT IS OKAY. IT IS A LOAN SET. THIS IS REPORT 1 OF 1 FOR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60584 DRILL BIT Ø2.7 CALIBR L210/185 3FLUTE BIT,DRILL HTW SYNTHES BETTLACH 8901254

    Patients

    Seq Age Sex Outcome Treatment
    1