BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUC-FORC W/POINT RATCH-LOCK L130

    MDR report key: 3173837 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03225
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    April 25, 2011
    Report Date
    April 26, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE ADDITIONAL EVALUATION REVEALED THAT THE PRESENT INSTRUMENTS SHOW CORROSION. THE INSTRUMENTS CONFORMED TO OUR SPECIFICATIONS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS CORROSION ON THE INSTRUMENTS AFTER THE STERILIZATION PROCESS. THE INSTRUMENTS WERE NEW AND HAD NEVER USED BEFORE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273540 REDUC-FORC W/POINT RATCH-LOCK L130 HTD SYNTHES GMBH 3583283

    Patients

    Seq Age Sex Outcome Treatment
    1