BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRONT CUTTER

    MDR report key: 2883660 · Received December 21, 2012

    Report

    Report Number
    8030965-2012-01633
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    November 22, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION IS ON GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING PAPERS AND RAW MATERIAL WERE REVIEWED AND ALL MET SPECIFICATION. THE FRACTURE SURFACE IS HOMOGENOUS WHAT INDICATES MATERIAL CONFORMITY TO THE SPECIFICATIONS AS WELL. WE THEREFORE CONCLUDE THAT A MECHANICAL OVERLOAD CAUSED THE BREAKAGE. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE THE FRONT CUTTER BROKE WITH NO REPORTED CONSEQUENCE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRONT CUTTER FRONT CUTTER HXZ SYNTHES GMBH 7961030

    Patients

    Seq Age Sex Outcome Treatment
    1