BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNREAM REAMER HEAD Ø10.5

    MDR report key: 3141375 · Received June 3, 2013

    Report

    Report Number
    8030965-2013-02618
    Event Type
    Malfunction
    Date Received
    June 3, 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. THE INVESTIGATION COULD NOT REACH A CONCLUSION, AS THE VISUAL INSPECTION DID NOT DETERMINE THIS COMPLAINT TO BE VALID. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    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. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE ADDITIONAL EVALUATION SHOWED THAT THE INVESTIGATION OF THE MEDULLARY CAVITY DRILL HEADS SHOWED 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS RUST ON THE DRILL HEAD. THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243742 SYNREAM REAMER HEAD Ø10.5 HTO SYNTHES GMBH 18990

    Patients

    Seq Age Sex Outcome Treatment
    1