BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE HOLDING FORCEPS SELF-CENTER SPEED-L

    MDR report key: 3171556 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-03179
    Event Type
    Malfunction
    Date Received
    June 15, 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

    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. (B)(6). MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. INVESTIGATIONS SHOWED THAT THE INSTRUMENTS CONFORM TO SPECIFICATIONS. THERE WERE VISIBLE SIGNS OF RUST, INDICATIVE OF IMPROPER STORAGE OF THE INSTRUMENTS IN AREAS OF HIGH MOISTURE. THE STAINLESS STEEL IS ONLY RUST-RESISTANT AND WILL FORM RUST IF LEFT IN CONTACT WITH MOISTURE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: AFTER THE STERILIZATION PROCESS ON (B)(6) 2011, CORROSION WAS OBSERVED ON THE DEVICE. REPORTEDLY, THE INSTRUMENT WAS NEW AND HAD NEVER BEEN USED BEFORE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272578 BONE HOLDING FORCEPS SELF-CENTER SPEED-L HTD SYNTHES GMBH 3583290

    Patients

    Seq Age Sex Outcome Treatment
    1