BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULATED ECCENTER EXTRACTOR F/GUIDE B

    MDR report key: 3161447 · Received June 11, 2013

    Report

    Report Number
    8030965-2013-02873
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    June 25, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THIS INVESTIGATION REPORT INDICATES THAT THE TIP OF THE ARTICULATED ECCENTER EXTRACTOR GUIDE WAS DAMAGED AND TEETH OF THE ECCENTER EXTRACTOR GUIDE BROKE OFF. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THE ACCENTED EXTRACTOR WAS IN ACCORDANCE MANUFACTURED AND MATERIAL SPECIFICATIONS. BASED ON THESE FINDINGS, THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES AND THE EXTRACTOR MAY NOT HAVE BEEN MOUNTED CORRECTLY DURING IMPLANT SURGERY. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    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. DEVICE HISTORY RECORD REVIEW: MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    THE TEETH OF THE ARTICULATED ECCENTER EXTRACTOR GUIDE BROKE DURING SURGERY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262521 ARTICULATED ECCENTER EXTRACTOR F/GUIDE B HWB SYNTHES GMBH 10-0419

    Patients

    Seq Age Sex Outcome Treatment
    1