BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIOSTEAL ELEVATOR, CURVED, 14MM WIDE

    MDR report key: 3192534 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-04115
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    August 28, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. THE EVALUATION REVEALED THAT THE TRACES VISIBLE ON THE SURFACE CONSIST NOT ONLY OF RUST, BUT ALSO OF ORGANIC RESIDUE. WE SUSPECT THAT THESE DEPOSITS FORMED OUT OF RESIDUE FROM THE CLEANING AND STERILIZATION PROCESS. IT CAN BE SAID IN GENERAL REGARDING RUST FORMATION THAT ALL MATERIALS, INCLUDING SO-CALLED RUST-FREE STEEL METALS, ARE ONLY CONDITIONALLY RUST-RESISTANT. PLEASE NOTE THAT THESE ITEMS REQUIRE SPECIAL CARE. THEY WILL BE RUST RESISTANT ONLY AS LONG AS THEY ARE IMMEDIATELY DRIED AND PLACED IN DRY STORAGE. NO PRODUCT DEFECT WAS ABLE TO BE FOUND. HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    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. REPORTED DATE: (B)(6) 2012. DEVICE IS EXEMPT. DEVICE IS MARKETED AND SOLD IN THE U.S. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENTS HAVE RUST. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294375 PERIOSTEAL ELEVATOR, CURVED, 14MM WIDE HTE SYNTHES GMBH 5910686

    Patients

    Seq Age Sex Outcome Treatment
    1