BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEND-IRON F/PL 2.4-3.5 L145

    MDR report key: 3171568 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-03388
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    June 2, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    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. OUR INVESTIGATIONS HAVE SHOWN THAT THE RETURNED INSTRUMENT CONFORMS TO OUR SPECIFICATIONS. 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. CONCERNING THE VISIBLE SIGNS OF CORROSION IT HAS TO BE POINTED OUT THAT EVEN THE SO-CALLED STAINLESS STEEL IS ONLY RUST-RESISTANT. THE CORROSION RESISTANCE IS ONLY ENSURED, WHEN THE PRODUCTS ARE STORED AT DRY CONDITIONS. IN ADDITION ALL METALLIC CONTACTS AT HUMID OR WET CONDITIONS MAY CREATE ELECTROLYTIC REACTIONS RESULTING IN CONTACT CORROSION. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. 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. RUST FREE ENDURANCE IS ONLY POSSIBLE IF THE MATERIAL IS ALWAYS IMMEDIATELY DRIED AND STORED IN A DRY AREA. THEREFORE, THE COMPLAINT CONDITION IS RELATED TO THE IMPROPER STORAGE OF THE DEVICE. IN THIS REGARD IT IS NOTED TO BE AWARE OF THE GENERAL GUIDELINES FOR REPROCESSING, CARE AND MAINTENANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS CORROSION AFTER THE FIRST STERILIZATION. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272582 BEND-IRON F/PL 2.4-3.5 L145 HXP SYNTHES GMBH 3614827

    Patients

    Seq Age Sex Outcome Treatment
    1