BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø1.5 W/STOP L44.5/6 2FLUTE

    MDR report key: 3173946 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03418
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 20, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ACTUAL EVENT DATE NOT KNOWN. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE INVESTIGATION HAS SHOWN THAT THE FRACTURE FACE OF THE DRILL BIT IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. AS NO DETAILS ABOUT THE EVENT WERE PROVIDED WE CAN ONLY ASSUME THAT TOO MUCH LATERAL STRESS WAS APPLIED ONTO THIS DEVICE. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE EXAMINATION OF THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL ABILITY. WE PRODUCED (B)(4) PIECES OF THIS LOT AND ALL ARE SOLD MEANWHILE. WE ARE NOT AWARE OF ANY OTHER BREAKAGE OR COMPLAINT REGARDING TO THIS LOT. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. AS NO DETAILS ABOUT THE EVENT WERE PROVIDED, WE CAN ONLY ASSUME THAT TOO MUCH LATERAL STRESS WAS APPLIED ONTO THIS DEVICE. THUS, THE DEVICE FAILURE IS RELATED TO THE CONDITIONS OF USE AND OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL BIT BROKE IN THE PATIENT ON THE FIRST USE. ALL BROKEN BITS WERE REMOVED FROM THE PATIENT. THE HOSPITAL IS NOT WILLING TO PASS ON ANY PATIENT DETAILS OR X-RAYS. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274475 DRILL BIT Ø1.5 W/STOP L44.5/6 2FLUTE HTW SYNTHES GMBH F-10866

    Patients

    Seq Age Sex Outcome Treatment
    1