BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3

    MDR report key: 6909363 · Received October 2, 2017

    Report

    Report Number
    9612488-2017-10503
    Event Type
    Injury
    Date Received
    October 2, 2017
    Date of Event
    September 12, 2017
    Report Date
    September 13, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTW
    UDI-DI
    07611819166264
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING INVESTIGATION WAS PERFORMED. A PORTION OF APPROXIMATELY 10 MM OF GROOVED PORTION AND INCLUDING THE TIP IS BROKEN OFF. THE REMAINING GROOVED PORTION SHOWS MARKS AND WEAR OF FORCIBLE USE. AS RELEVANT FOR THE COMPLAINT CONDITION (THE DRILL BIT IS BROKEN) THE WEB THICKNESS (D2 AND D4), THE WIDTH OF LAND PHASE (S AND Z), THE HELIX ANGLE, THE DRILL DIAMETER (D6) AND THE HARDNESS WERE IDENTIFIED AND MEASURED. THE MEASUREMENTS WERE PERFORMED NEAR AT THE BREAKAGE. BASED ON THE ORIGINAL LENGTH OF THE DRILL (140MM) IT CAN BE ASSUMED THAT A PIECE OF APPROX. 9.60MM WAS BROKEN OFF. ORIGINAL LENGTH CAN¿T BE DETERMINED BECAUSE BROKEN OFF PART IS MISSING. THE DRILL WAS ABORTED IN THE FRONT AREA. ALL RELEVANT FEATURES INCLUDING THE HARDNESS HAVE BEEN MEASURED AND MEET THE SPECIFICATIONS SET FORTH IN THE RELEVANT DRAWING. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATIONS AND WITH THE INTERNATIONAL STANDARD OF STAINLESS STEEL. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS COMPLAINT. A PROBABLE REASON FOR THE DAMAGE COULD BE A METALLIC CONTACT OR WITH BONE MATERIAL BLOCKED FLUTES. FOR EFFECTIVE CHIP REMOVAL FROM THE POINT, IT IS NEVERTHELESS NECESSARY TO WITHDRAW THE ENTIRE DRILL FROM THE HOLE AT FREQUENT INTERVALS TO AVOID CHIP CONGESTION. THEREFORE, WE ASSUME THAT THIS OCCURRENCE IN COMBINATION WITH A MECHANICAL OVERLOAD SITUATION HAS CAUSED THE BREAKAGE. PLEASE ALSO NOTE; BLUNT DRILL BITS REQUIRE MORE MECHANICAL POWER DURING THE APPLICATION, THEREFORE WE WOULD LIKE TO DRAW YOUR ATTENTION ON PAGE 4 IN THE LEAFLET ¿IMPORTANT INFORMATION¿ IN THE RELEVANT DRAWING: CHECK INSTRUMENTS FOR SOUND SURFACES, AND CORRECT ADJUSTMENT AND FUNCTION. DO NOT USE SEVERELY DAMAGED INSTRUMENTS, INSTRUMENTS WITH UNRECOGNIZABLE MARKINGS, CORROSION, OR BLUNT CUTTING SURFACES. A FINAL ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE MANUFACTURING INVESTIGATION RESULTS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCE BUT WAS CAUSED DURING A MECHANICAL OVERLOADING SITUATION. NEITHER A PRODUCT NOR A MATERIAL RELATED FAULT WAS FOUND. CORRECTED FROM PRODUCT MALFUNCTION ONLY TO SERIOUS INJURY AND PRODUCT MALFUNCTION AS THE DRILL BIT BROKE INTRAOPERATIVELY AND A FRAGMENT REMAINS IN THE PATIENT. (B)(4). 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 USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTERS PHONE NUMBER: (B)(6). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART: 323.062 / LOT: 9032517. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 01 JULY 2014. NO NCR'S WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. 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

    PROCEDURE WAS COMPLETED WITH SIMILAR PRODUCT. REPORTEDLY THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DRILL BIT BROKE WHILE BEING USED ON PATIENT DURING A SURGERY. PATIENT IS FINE. SURGERY WAS COMPLETED SUCCESSFULLY. A 5 MINUTES PROLONGATION OF THE SURGERY WAS REPORTED. FRAGMENTS WERE GENERATED. FRAGMENTS WERE NOT REMOVED AS IT WOULD CAUSE MORE TRAUMA TO THE PATIENT TO REMOVE IT. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688351 DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3 BIT, DRILL HTW SYNTHES BETTLACH 9032517 07611819166264

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention