BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM DRILL BIT W/DEPTH MARK QC/110MM

    MDR report key: 7043338 · Received November 17, 2017

    Report

    Report Number
    3000270450-2017-10405
    Event Type
    Malfunction
    Date Received
    November 17, 2017
    Date of Event
    October 25, 2017
    Report Date
    October 25, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    GFG
    UDI-DI
    07611819158962
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW WAS COMPLETED. MANUFACTURING LOCATION: (B)(4). SUPPLIER: (B)(4). MANUFACTURING DATE: 14.APR.2010 . 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. DEVICE RETURN. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (DRILL BIT, PART NUMBER 310.534, LOT NUMBER F-10048). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING THE FLUTED TIP IS BROKEN OFF. THE BROKEN FRAGMENT WAS NOT RETURNED. THE COMPLAINT IS CONFIRMED. THE VISUAL INSPECTION HAS SHOWN THAT APPROXIMATELY 30 MM FROM THE FLUTED TIP SECTION IS BROKEN OFF. THE BROKEN OFF FRAGMENT WAS NOT RETURNED FOR EVALUATION. THE DRILL BIT SHOWS NO OTHER DAMAGES OR SIGNS OF USE. THE REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THIS DRILL BIT WAS MANUFACTURED IN APRIL 2010 ACCORDING TO THE SPECIFICATIONS. NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION WERE FOUND. THE SAMPLE OF THE HARDNESS DURING MANUFACTURING OF THE PRODUCTS HAS SHOWN NO DEVIATIONS. BASED ON THE PROVIDED INFORMATION THE ROOT CAUSE IS UNKNOWN. THE MOST PROBABLE ROOT CAUSE IS A MECHANICAL OVERLOADING SITUATION HAS CAUSED THIS BREAKAGE. 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 TWO (2) SEPARATE DRILL BITS WERE FOUND TO HAVE THE CUTTING PORTION BROKEN. NO PATIENT OR SURGICAL INVOLVEMENT WAS REPORTED. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT WITH DEPTH MARK. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819246 2.0MM DRILL BIT W/DEPTH MARK QC/110MM BIT, MILLING STERILE AND NON GFG SYNTHES SELZACH F-10048 07611819158962

    Patients

    Seq Age Sex Outcome Treatment
    1