BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKSCR Ø2.4 SELF-TAP L16 TAN

    MDR report key: 3170038 · Received June 14, 2013

    Report

    Report Number
    2520274-2013-03431
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 15, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: AN ADDITIONAL EVALUATION WAS PERFORMED BY SYNTHES (B)(4) AND THE REPORT INDICATES: VISUAL INSPECTION SHOWS THE SURFACE HAVE DISCOLOURED AREAS. THIS IS INDICATIVE OF DEVICE WAS SUBJECT TO MULTIPLE WASHING PROCESSES/CYCLES WHICH LED TO AN ACCELERATED DISCOLORATION OF THE DEVICE. THIS IS ALSO DUE TO DEVICE IS MADE OF ANODISING TITANIUM. THAT MEANS THIS IS AN OXIDATION WITHIN UM AREA. ACCORDING OF THE THICKNESS OF THIS OXIDATION COATING THE VISIBLE COLOUR IS CHANGING. IF THIS COATING IS CHANGING BECAUSE OF SOME CIRCUMSTANCES LIKE SPLASHES WITH A LIQUID, THE COLOUR WILL ALSO CHANGE. ALTHOUGH DISCOLORED, THE FUNCTIONALITY OF THE DEVICE(S) REMAINS INTACT. PRODUCT CODE HWC.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH VA-LCP 2 COLUMN DISTAL RADIUS PLATE AND SCREW CONSTRUCT ON (B)(6) 2011. REPORTEDLY THE HEALING PROCESS WAS COMPLETED. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 FOR REMOVAL OF HARDWARE. DURING THE IMPLANT REMOVAL, IT WAS NOTED THAT THE COLOR OF THE VA LOCKING SCREWS CHANGED AND THE SCREWS APPEARED TO HAVE CORROSION. THIS IS 3 OF 9 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Description of Event or Problem · 1

    THIS IS 3 OF 9 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271564 LOCKSCR Ø2.4 SELF-TAP L16 TAN HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR