BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAMP RADIOLUC

    MDR report key: 3171101 · Received June 14, 2013

    Report

    Report Number
    8030965-2013-03232
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    April 28, 2012
    Report Date
    May 30, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. 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. THE INVESTIGATION OF THE COMPLAINED CLAMPS SHOWS THAT MECHANICAL OVERLOADING IS THE MAIN SOURCE OF THIS BREAKAGE. THE APPEARANCE OF THE FRACTURES IS SIMILAR TO THE STANDARD BREAKING PATTERN WHEN MORE THAN 4NM HAS BEEN APPLIED DURING THE SERIAL COMPONENT MANUFACTURING. AS STATED IN THE SURGICAL TECHNIQUE CLAMPS MUST NOT BE TIGHTENED WITH MORE THAN 3NM. 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. NO PRODUCT FAULT COULD BE DETECTED AND WE ARE NOT AWARE OF ANY OTHER SIMILAR REPORTS REFERRING TO THE COMPLAINED LOT NUMBERS IN QUESTION. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING. INVESTIGATION RESULTS REVEALED THAT MECHANICAL OVERLOADING IS THE MAIN SOURCE OF THIS CLAMP BREAKAGE, THUS THE DEVICE FAILURE IS RELATED TO THE CONDITIONS OF USE AND OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS FOUND BROKEN AFTER SURGERY. 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
    270899 CLAMP RADIOLUC HXD SYNTHES GMBH 0010413

    Patients

    Seq Age Sex Outcome Treatment
    1