BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP 3.5 7HO L98 SST

    MDR report key: 3001376 · Received March 13, 2013

    Report

    Report Number
    8030965-2013-00869
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    December 20, 2012
    Report Date
    February 18, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K082807
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. OUR INVESTIGATION HAS SHOWN THAT THERE IS INDEED A HAIR BETWEEN THE FIRST AND THE SECOND PEEL POUCH AS COMPLAINED. THIS IS CLEARLY A MANUFACTURING FAULT, WHICH WAS REGRETTABLY NOT DETECTED DURING THE FINAL INSPECTION OF THE PACKAGE. EVEN THIS DEVICE IS PACKED IN CLEAN ROOM, WHERE THE EMPLOYEES HAVE TO WEAR A HAIR COVER AND A MASK; SUCH AN OCCURRENCE CAN HAPPEN IN VERY RARE CASES. THEREFORE WE ASSUME THAT THIS IS AN ISOLATED CASE. TO AVOID SUCH AN OCCURRENCE IN THE FUTURE THE RESPONSIBLE EMPLOYEES WERE INFORMED ABOUT THIS COMPLAINT AND INSTRUCTED ACCORDINGLY. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE HOSPITAL PERSONNEL REPORTED FINDING HAIR IN THE STERILE PACKED LCP PLATE. THE DEVICE WAS REPORTEDLY NOT INVOLVED IN AN OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105952 LCP 3.5 7HO L98 SST HRS SYNTHES GMBH 8021939

    Patients

    Seq Age Sex Outcome Treatment
    1