BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAW INS.BIP.MARYLAND DISS.FEN.5/310MM

    MDR report key: 4080924 · Received August 29, 2014

    Report

    Report Number
    2916714-2014-00694
    Event Type
    Malfunction
    Date Received
    August 29, 2014
    Date of Event
    July 31, 2014
    Report Date
    August 29, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    GEI
    PMA / PMN Number
    NARRATIVE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON: (B)(4) 2014, 510 (K) CODES: K001330 AND K003608. MANUFACTURING SITE EVALUATION: WITHOUT FURTHER KNOWLEDGE ABOUT THE CIRCUMSTANCES SURROUNDING THE BREAK, OEM ASSUMES, THAT THE ROOT CAUSE FOR CRACKED CERAMIC WAS A MECHANICAL OVERSTRESS. THE ENCLOSED CERAMIC-PART IS NOT DEFINITIVELY THE COMPLETED BROKEN OFF PIECE. REGARDING THE QUESTION OF MANUFACTURING PROBLEMS: THE 100% VISUAL TEST SPECIFICATION FOR THE TIP ENCLOSES THE POINTS "CHECKING OF STAINS, DEBRIS, PORES, CRACKS OR ANY FURTHER IMPURITIES". THE OEM DOCUMENTS ARE SHOWING NO HINTS FOR SUCH A PROBLEM AS A CRACKED CERAMIC BODY. OEM DOCUMENTS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO THE SPECIFICATIONS DURING THE TIME OF PRODUCTION.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). COMPLAINT STATES: WHEN THE CUSTOMER USED THIS PRODUCT IN THE SURGERY, THE CERAMIC BROKE. THOUGH THE FRAGMENT HAD FALLEN INTO THE PATIENT'S BODY, IT WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527647 JAW INS.BIP.MARYLAND DISS.FEN.5/310MM UTILITY FORCEPS, GEI/HGI GEI AESCULAP AG & CO. KG PM438R 61860687

    Patients

    Seq Age Sex Outcome Treatment
    1 Other