BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNREAM REAMER HEAD Ø14.5

    MDR report key: 3132443 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02426
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    February 24, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    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. ADDITIONAL EVALUATION: THE INVESTIGATION OF THE MEDULLARY CAVITY DRILL HEADS COMPLAINED ABOUT HAS SHOWED THAT INDEED SOME OF THEM SHOW SIGNS OF CORROSION. THESE VISIBLE TRACES CAN BE EASILY REMOVED MECHANICALLY. THEREFORE WE CAN BE CONFIDENT IN INFERRING THAT THIS IS A CASE OF CONTACT CORROSION. CONCERNING THE FORMATION OF RUST, IT CAN BE SAID AS A GENERAL RULE THAT ALL MATERIALS, EVEN SO CALLED STAINLESS STEELS, HAVE ONLY A LIMITED RESISTANCE TO RUST. THIS RESISTANCE TO RUST CAN ONLY BE GUARANTEED WHEN THE MATERIAL IS STORED DRY AND WITHOUT CONTACT WITH OTHER METALLIC OBJECTS. ALL CONTACTS BETWEEN METALS IN HUMID OR WET CONDITIONS RESULT IN ELECTROLYTIC REACTIONS WITH ENSUING CONTACT CORROSION. THE PRESENT CASE HAS TO DO WITH NORMAL SIGNS OF WEAR. MANUFACTURING DATE REPORTED INCORRECTLY IN PREVIOUS MW. PLACEHOLDER.

    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. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    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 INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS RUST ON THE SURFACE. 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
    235185 SYNREAM REAMER HEAD Ø14.5 HTO SYNTHES GMBH 18992

    Patients

    Seq Age Sex Outcome Treatment
    1