BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE CUTTER LRG

    MDR report key: 3160792 · Received June 11, 2013

    Report

    Report Number
    8030965-2013-03062
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    November 14, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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.(B)(4)

    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. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE DEVICE IS RUSTED AND OUR VISUAL INSPECTION HAS SHOWN THAT THE PLIERS SHOW HEAVY RUST SPOTS AND DISCOLORATION. OUR INVESTIGATION OF THE REJECTED INSTRUMENT DETERMINED THAT THERE ARE VISIBLE SIGNS OF NOT JUST RUST BUT ALSO THAT SOME ORGANIC REMAINS EXIST. WE ASSUME THAT THIS RESIDUE WAS FORMED OR REMAINED AFTER THE CLEANING AND STERILIZATION PROCESS. NO PRODUCT FAULT COULD BE DETECTED. 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. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON CONFORMANCES AND MAY BE RELATED TO THE CLEANING AND MAINTENANCE OF THE DEVICE. REGARDING RUST, IT CAN GENERALLY BE STATED THAT ALL MATERIALS, EVEN SO CALLED RUST FREE STEEL, ARE ONLY RUST FREE FOR A LIMITED TIME. PLEASE ENSURE THAT THESE ARTICLES REQUIRE SPECIAL CAREFUL HANDLING. RUST FREE ENDURANCE IS ONLY POSSIBLE IF THE MATERIAL IS ALWAYS IMMEDIATELY DRIED AND STORED IN A DRY AREA. NO PRODUCT ERROR COULD BE DETERMINED. CONCLUSION ¿IT WAS CLEARLY DETERMINED THAT DEVICE IS RUSTED. RUST FREE ENDURANCE IS ONLY POSSIBLE IF THE MATERIAL IS ALWAYS IMMEDIATELY DRIED AND STORED IN A DRY AREA. THE COMPLAINT CONDITION IS RELATED TO THE IMPROPER STORAGE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CABLE CUTTER SHOWS SIGNS OF HEAVY RUSTING AND DISCOLORATION. 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
    263206 CABLE CUTTER LRG HXZ SYNTHES GMBH A7QA24

    Patients

    Seq Age Sex Outcome Treatment
    1