BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE-SM MINI-QUICK-COUPL

    MDR report key: 3151247 · Received June 6, 2013

    Report

    Report Number
    8030965-2013-02776
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    April 18, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ACTUAL EVENT DATE NOT KNOWN. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. INVESTIGATION OF THE COMPLAINED DEVICE REVEALED THAT THE COUPLING DEVICE IS RUSTY AND THE HANDLE HAD IRON OXIDE PARTICLES CLOSE TO THE SAFETY PIN. IT CAN BE SUPPOSED THAT THE ABRASION DUE TO ASSEMBLING AND DISASSEMBLING FROM THE DIFFERENT PARTS OF THE HANDLE LEAD TO A DEPOSITION OF IRON PARTICLES. THE CLEANING AND STERILIZATION OF THE INSTRUMENT MAY HAVE CAUSED THE DISCOLORED AREA CLOSE TO THE SAFETY PIN AND THE OXIDATION OF THE IRON PARTICLES. THE INVESTIGATION CONDUCTED AT THE MATERIAL SCIENCE AND TESTING LAB LEAD TO THE CONCLUSION THAT ABRASION WAS CAUSED DUE TO ASSEMBLING AND DISASSEMBLING FROM THE DIFFERENT PARTS OVER TIME. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. CONCLUSION - THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. THE PRESENT LIGHT RUSTY COLORED FILM CLOSE TO THE SAFETY PIN RESULTS FROM A TRANSFER FROM THE IRON OXIDE PARTICLES, AND CAN BE CONSIDERED SUPERFICIAL DISCOLORATION AND THE DEVICE FAILURE IS RELATED TO THE CLEANING AND MAINTENANCE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COUPLING IS RUSTY AND NOT HOLDING. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250778 HANDLE-SM MINI-QUICK-COUPL LXH SYNTHES GMBH 1913961

    Patients

    Seq Age Sex Outcome Treatment
    1