BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP DRILL SLEEVE 3.5 F/DRILL BITS Ø2.8

    MDR report key: 3145573 · Received June 4, 2013

    Report

    Report Number
    8030965-2013-02651
    Event Type
    Malfunction
    Date Received
    June 4, 2013
    Date of Event
    March 28, 2011
    Report Date
    March 31, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ADDITIONAL NARRATIVE: THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PRODUCT CODE CORRECTION: FZW. PLACEHOLDER.

    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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RETURNED FOR VISUAL INSPECTION AND THE EVENT WAS CONFIRMED. THE MACROSCOPIC AND MICROSCOPIC INVESTIGATION IDENTIFIED THE BURR AS BEING A PART FROM A TITANIUM IMPLANT. THE COLORED SURFACE ON SOME AREAS OF THE METAL PART SHOWED THAT THIS BURR CAME OFF AN IMPLANT, MAYBE A SCREW AND LIKELY TOUCHED ANOTHER METALLIC PART DURING THE SURGERY. NO PRODUCT FAULT COULD BE DETECTED AND ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. WHILE WE CAN ONLY SPECULATE THAT THIS BURR CAME OFF ANOTHER IMPLANT AND MAYBE TOUCHED ANOTHER METALLIC PART BEING IMPLANTED DURING THE SURGERY, WE ARE UNABLE TO GIVE A CONCLUSIVE STATEMENT REGARDING A POSSIBLE FAILURE REASON AND THE COMPLAINT CONDITION IS DUE TO AN UNKNOWN CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BURR WAS FOUND IN THE PATIENTS BODY. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246225 LCP DRILL SLEEVE 3.5 F/DRILL BITS Ø2.8 FZX SYNTHES GMBH 2232982

    Patients

    Seq Age Sex Outcome Treatment
    1