BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3

    MDR report key: 3082073 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-02035
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MEASURABLE DIMENSIONS WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE DRAWINGS AND AO ASIF SPECIFICATIONS. THE REVIEW OF THE RAW MATERIAL TEST CERTIFICATE AND THE MANUFACTURING DOCUMENTS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, TENSILE STRENGTH, STRUCTURAL STABILITY AND MANUFACTURING. THE VALUES CORRESPOND TO THE AO ASIF SPECIFICATIONS AND TO THE INTERNATIONAL STANDARD. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LEAD TO THIS OCCURRENCE. WE CAN ONLY ASSUME THAT TOO MUCH MECHANICAL FORCE HAD BEEN APPLIED DURING THE SURGERY.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: THE TIP OF A DRILL BIT FOR QUICK COUPLING BROKE DURING SURGERY ON (B)(6) 2013. THE SURGEON TRIED TO REMOVE THE BROKEN TIP BUT COULD NOT REMOVE IT. THE SURGEON DECIDED TO KEEP IT IN THE BONE. THE MATERIAL WAS RECEIVED (B)(6) 2013. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183810 DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3 HTW SYNTHES GMBH F-11182

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention