BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.0MM DRILL BIT/QC/195MM

    MDR report key: 3917469 · Received July 7, 2014

    Report

    Report Number
    2520274-2014-12420
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    May 15, 2014
    Report Date
    June 10, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HSZ
    PMA / PMN Number
    PK962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT NO NCRS WERE GENERATED DURING PRODUCTION. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT THE INVESTIGATION OF THE COMPLAINED DRILL BIT HAS SHOWN THAT THE TIP IS BROKEN OFF DUE TO A MOMENTARY OVERLOAD. THE CAUSE OF THE OVERLOAD CAN NOT BE DEFINITELY DETERMINED. THE LOAD LIMIT OF THE MATERIAL HAS BEEN EXCEEDED BY AN UNINTENDED BENDING MOMENT AND FINALLY LED TO A BREAKAGE. THE FRACTURE SURFACE IS HOMOGENEOUS, INDICATING A PROPER QUALITY OF MATERIAL. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HTW. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE LOT NUMBER PROVIDED COULD NOT BE VERIFIED; THEREFORE, FURTHER INVESTIGATION CANNOT BE PERFORMED. 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.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 THAT DURING THE REMOVAL OF A HIP HEAD NECROSIS SURGERY THE DRILL BIT BROKE. THE BROKEN FRAGMENT REMAINED IN PATIENT. THERE WAS NO DELAY IN THE PROCEDURE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393914 6.0MM DRILL BIT/QC/195MM INSTR, SURGICAL, ORTHO, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT HSZ SYNTHES BETTLACH 2010

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR