BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM

    MDR report key: 4151221 · Received October 8, 2014

    Report

    Report Number
    9612488-2014-10432
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 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

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. NO NON-CONFORMANCE 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. 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

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS COMPLETED: THE MISSING PORTION OF THE DRILL BIT IN QUESTION MEASURES APPROXIMATELY 12MM. THE REMAINING GROOVED PORTION AND THE SHAFT SHOW MARKS OF USE AND WEAR. THE CONDITION OF THE DRILL BIT BEFORE THE OPERATION IS UNKNOWN. SYNTHES INSTRUMENTS SHOULD BE INSPECTED TO DAMAGE AND WEAR AFTER PROCESSING, PRIOR TO STERILIZATION. 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. THE DIMENSIONS OF THE BROKEN DRILL BIT WERE AS FAR AS POSSIBLE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. TAKING INTO ACCOUNT ALL RELEVANT FINDINGS, IT IS LIKELY THAT THE DRILL BIT BROKE DURING USE DUE TO A MECHANICAL OVERLOADING SITUATION. IN ADDITION THE DRILL BIT POSSIBLY WAS EXPOSED TO EXTENDED LATERAL STRESS OR GOT IN CONTACT WITH OTHER METALLIC PARTS. NEITHER A PRODUCT NOR A MATERIAL RELATED FAULT WAS FOUND. 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: THE 4.2MM DRILL BIT BROKE WHEN THE SURGEON WAS TRYING TO LOCATE AND CENTER THE TIP OF THE DRILL BIT INTO THE DISTAL LOCKING HOLE FOR THE EXPERT TIBIA NAIL (ETN) DISTAL LOCKING. THE TIP OF THE DRILL BIT BROKE INSIDE THE PATIENT. THE LENGTH OF THE DRILL BIT LEFT INSIDE THE PATIENT WAS ABOUT 10MM. THERE WAS NO SURGICAL DELAY. THE PATIENT¿S CONDITION IS REPORTED AS DOING WELL AND HAS BEEN DISCHARGED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632828 4.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM BIT, DRILL HTW SYNTHES BETTLACH 8901263

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR