BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL-INSERTER

    MDR report key: 3103118 · Received May 9, 2013

    Report

    Report Number
    8030965-2013-02165
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 16, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ADDITIONAL EVALUATION WAS PERFORMED AND THE REPORT STATED THE FOLLOWING: THE INVESTIGATION HAS SHOWN THAT THE DRIVING SHAFT IS INDEED BROKEN AT THE HOLE OF THE LOCKING SPINDLE. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THIS INSTRUMENT WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. NO ABNORMAL FINDINGS WERE IDENTIFIED. THE BROKEN SURFACE IS HOMOGENOUS WHAT INDICATES MATERIAL CONFORMITY AS WELL. WE SUPPOSE THAT SIMPLY TOO MUCH APPLIED MECHANICAL FORCE WELL BEYOND ITS CALCULATED DESIGN DURING USE CAUSED THE BREAKAGE. PLACEHOLDER.

    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.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE MIDDLE PART OF THE IMPLANT INSERTER BROKE ON (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
    204437 IMPL-INSERTER FZX SYNTHES GMBH 3719791

    Patients

    Seq Age Sex Outcome Treatment
    1