BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENDING IRON FOR 2.7MM & 3.5MMPLATES

    MDR report key: 3023460 · Received March 27, 2013

    Report

    Report Number
    1719045-2013-10486
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    August 22, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. MANUFACTURING EVALUATION REVEALED THE DEVICE WAS RETURNED IN GOOD CONDITION. THERE WERE SOME DENTS AND DINGS NOTICEABLE. THE CUSTOMER HAD STAMPED THEIR IDENTIFICATION ON THE BENDING IRON. THERE IS SOME POSSIBLE RUST LOCATED BETWEEN THE SLOTS. THE MATERIAL AND HARDNESS VALUES WERE DEEMED TO BE WITHIN TOLERANCES. DUE TO THE UNKNOWN ROOT CAUSE OF THE ISSUE, THE UNKNOWN DATE OF MANUFACTURING AND THE INVESTIGATION CONDUCTED, THIS COMPLAINT IS DEEMED TO BE INDETERMINATE FROM A MANUFACTURING POSITION.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE RUSTING INSTRUMENTS IN THE TRAYS. THE FACILITY HAS HAD THESE SPECIFIC TRAYS FOR ABOUT 7-8 YEARS. THE INSTRUMENTS ARE IN QUARANTINE AT THE FACILITY. THERE WAS NO PATIENT INVOLVEMENT NOTED. THIS IS REPORT 2 OF 4 FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THIS REPORT IS FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126350 BENDING IRON FOR 2.7MM & 3.5MMPLATES LXH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1