BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE JACOBS CHUCK WITH KEY

    MDR report key: 3191440 · Received June 26, 2013

    Report

    Report Number
    8030965-2013-02764
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    February 10, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. SUBJECT DEVICE HAS BEEN RECEIVED AND EVALUATED. NO DEVICE NONCONFORMANCES WERE DETECTED EXCEPT FOR SOME SURFACE CORROSION/RUST AT ONE END. IT WAS REPORTED THAT THE CORROSION WAS DUE TO IMPROPER CLEANING AND STORAGE. THE DHR FOR THIS LOT HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER NOTED CORROSION ON THE TOP PORTION OF THE PART, JACOBS CHUCK ASSEMBLY. IT WAS NOT REPORTED THAT THE PART WAS USED IN THAT CONDITION IN SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291508 LARGE JACOBS CHUCK WITH KEY JACOBS CHUCK WITH KEY HWE SYNTHES GMBH MA1102

    Patients

    Seq Age Sex Outcome Treatment
    1