BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNREAM REAMER HEAD Ø14

    MDR report key: 3173942 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03356
    Event Type
    Malfunction
    Date Received
    June 17, 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

    ADDITIONAL NARRATIVE: 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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE ADDITIONAL EVALUATION REVEALED THAT 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.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273080 SYNREAM REAMER HEAD Ø14 HTO SYNTHES GMBH 18439

    Patients

    Seq Age Sex Outcome Treatment
    1