BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT 1.3 MM, LENGTH 46/34MM

    MDR report key: 3931763 · Received July 14, 2014

    Report

    Report Number
    3000270450-2014-10049
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 16, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS COMPLETED: THE TIP OF THE DRILL BITS ARE BROKEN OFF. THE MEASURABLE DIMENSIONS OF THE BROKEN DRILL BITS WERE CHECKED AS FAR AS POSSIBLE AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATIONS. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING PAPERS SHOWED NO DEVIATION REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATIONS AND WITH THE INTERNATIONAL STANDARDS. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH LED TO THIS OCCURRENCE. IT IS LIKELY THAT TOO MUCH MECHANICAL FORCE HAD BEEN APPLIED DURING THE SURGERY (FOR EXAMPLE; TOO HIGH DRILL SPEED, HARD BONE OR POSSIBLE MOVEMENT IN A SLANTING POSITION). THESE ARE DELICATE DRILL BITS WHICH REQUIRE EXTRA CAUTION DURING USE. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE DRILL BIT WAS BROKEN. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411260 DRILL BIT 1.3 MM, LENGTH 46/34MM BIT, DRILL HTW SYNTHES SELZACH 414545

    Patients

    Seq Age Sex Outcome Treatment
    1