BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8MM DRILL BIT/QC/165MM

    MDR report key: 3781472 · Received April 30, 2014

    Report

    Report Number
    9612488-2014-10137
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 3, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTW
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS COMPLETED: OUR INVESTIGATION SHOWS THAT THE DRILL BIT IS BROKEN OFF AT THE TIP. THE DEVICE SHOWS SCRATCHES AND WEAR AND TEAR SIGNS ALL OVER ON THE SURFACE. THE BROKEN OFF PART IS NOT AVAILABLE FOR FURTHER INVESTIGATION. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THE BREAKAGE. DUE TO THE WEAR AND TEAR SIGNS, IT IS LIKELY THAT THIS PRODUCT WAS AN OFTEN AND INTENSIVE USED INSTRUMENT. IT IS LIKELY THAT THE BAD CONDITION OF THE DEVICE IN COMBINATION WITH AN APPLICATION OF HIGH MECHANICAL FORCE ON IT DURING THE SURGERY COULD FINALLY LEAD TO THE COMPLAINED ISSUE. BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. BLUNT DRILL BITS REQUIRE MORE MECHANICAL POWER DURING THE APPLICATION, THEREFORE WE RECOMMEND THAT BLUNT OR DAMAGED INSTRUMENTS NEED TO BE EXCHANGED BEFORE SURGERY. NO PRODUCT FAULT COULD BE DETECTED. 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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. NO NONCONFORMANCE REPORTS 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 DURING SURGERY THE DRILL BIT WAS BROKEN. NO OTHER INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260602 2.8MM DRILL BIT/QC/165MM BIT, DRILL HTW SYNTHES BETTLACH 2421646

    Patients

    Seq Age Sex Outcome Treatment
    1