BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 7H HD/5H SHAFT/LEFT

    MDR report key: 3020940 · Received March 26, 2013

    Report

    Report Number
    8030965-2013-10610
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    November 3, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K083694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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 DHR WAS REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED VISIBLE SPOTS ON THE TOP SIDE AND VISIBLE SPOTS ON THE BACKSIDE OF THE PART. THE VISUAL INSPECTION HAS SHOWN THAT THERE ARE INDEED RUSTY SPOTS ON THE ENGRAVED "R" SURFACE BUT ALSO OTHER VISIBLE SPOTS ON THE TOP SIDE AND ON THE BACKSIDE. THIS COMPLAINT WAS FOUND INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Additional Manufacturer Narrative · 1

    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 MANUFACTURING INVESTIGATION REPORTED IT WAS POSSIBLE THAT AN INADEQUATE WASHING PROCEDURE WAS THE MAIN SOURCE OF THE REPORTED EVENT. WITH REGARDS TO CORROSION IT CAN BE STATED, THAT ALL MATERIALS, INCLUDING SO CALLED STAINLESS STEEL ARE ONLY CONDITIONALLY RUST-RESISTANT. THE CORROSION RESISTANCE WILL ONLY BE ENSURED, WHEN CLEAN INSTRUMENTS ARE STORED UNDER DRY AND METALLIC-CONTACTLESS CONDITIONS. ALL METALLIC CONTACT WITH HUMID OR WET CONDITIONS CREATES ELECTROLYTIC REACTIONS WHICH LEAD TO CONTACT CORROSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 7 PLATES WERE FOUND, AND THEY APPEARED TO BE RUSTY. THIS IS 1 OF 7 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 7 FOR THIS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123219 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 7H HD/5H SHAFT/LEFT HRS SYNTHES GMBH 3194247

    Patients

    Seq Age Sex Outcome Treatment
    1