BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILOS LONG 3.5 8HO L200 SST

    MDR report key: 3222697 · Received July 12, 2013

    Report

    Report Number
    2520274-2013-04219
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 17, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K041860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE INVESTIGATION OF THE PHILOS HAD SHOWN THAT THERE ARE RUSTY SPOTS AROUND THE INDICATION ¿LONG¿. THIS CAN BE REMOVED BY BRUSHING WITH FOLLOWING ADEQUATE CLEANING PROCESS. PLEASE NOTE: REGARDING CORROSION IT CAN BE STATED, THAT ALL MATERIALS, INCLUDING SO CALLED STAINLESS STEEL AS WELL, ARE CONDITIONALLY ONLY RUST-RESISTANT. THE CORROSION RESISTANCE IS MAINTAINED ONLY, WHEN THE MATERIAL IS STORED ON A DRY AND METALLIC CONTACTLESS CONDITION. ALL METALLIC CONTACTS ON HUMID OR WET CONDITION CREATE ELECTROLYTIC REACTIONS WITH CONTACT CORROSION AS RESULT. THE PRESENT IMPLANT WAS AS FAR AS POSSIBLE ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. NO PRODUCT FAULT COULD BE DETECTED. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PLATE WAS WITHIN THE SET SMALL FRAGMENTS. NURSE NOTED THE PRESENCE OF RUST AROUND THE INDICATION LONG INSCRIBED ON THE BACK OF IT ON AN UNKNOWN DATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321830 PHILOS LONG 3.5 8HO L200 SST HRS SYNTHES USA 7733162

    Patients

    Seq Age Sex Outcome Treatment
    1