BEUDAMED
    FDA Adverse Event Other Summary report: N

    TITAN CONDYL PLT RT 5-HS HAND-M-KPR

    MDR report key: 4959931 · Received July 29, 2015

    Report

    Report Number
    9613350-2015-00916
    Event Type
    Other
    Date Received
    July 29, 2015
    Date of Event
    February 28, 2015
    Report Date
    July 18, 2015
    Manufacturer
    NORMED MEDIZIN-TECHNIK GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS WERE MADE AVAILABLE. IT WAS REPORTED THAT THE PLATE BROKE DURING SURGERY. VISUAL EXAMINATION OF RETURNED DEVICE: THE THIN TIP OF THE PLATE BROKE OFF. THE PLATE IS SLIGHTLY BENDED ON THE TIP-SIDE OF THE PLATE. POSSIBLE CAUSES FOR THE REPORTED EVENT ACCORDING TO SAP DFMEA: BREAKAGE OF THE PLATE DUE TO FATIGUE. BREAKAGE OF THE PLATE DUE TO OFF LABEL USE OF IMPLANT. POSSIBLE AS IT CAN BE THAT THERE WAS OFF LABEL USE AND THE PLATE WAS OVER STRESSED. BREAKAGE OF THE PLATE DUE TO USE OF NON COMPATIBILITY DEVICE DUE TO MISSING INSTRUCTIONS. POSSIBLE, AS IT CAN BE THAT THE PLATE BROKEN DUE TO USE OF A NON COMPATIBILITY DEVICE DUE TO MISSING INSTRUCTIONS. HOWEVER, BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4). .

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION BUT IT IS MENTIONED BY COMPLAINANT THAT IT WILL BE PROVIDED. NO SURGICAL REPORT OR X-RAYS WERE PROVIDED FOR REVIEW. A LOT NUMBER WAS RECEIVED FOR THE INSTRUMENT, THE INSTRUMENT HISTORY RECORDS WILL BE REVIEWED WITHIN THE INVESTIGATION PROCESS. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/ OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANTATION SURGERY WAS PLANNED WITH A TITAN CONDYL PLT RT 5-HS HAND-M-KPR ON (B)(6) 2015. IT WAS REPORTED THAT THE PLATE BROKE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492350 TITAN CONDYL PLT RT 5-HS HAND-M-KPR NORMED EXTREMITY TITANIUM HAND AND SMA HRS NORMED MEDIZIN-TECHNIK GMBH NA 6356/301C9

    Patients

    Seq Age Sex Outcome Treatment
    1 Other