BEUDAMED
    FDA Adverse Event Other Summary report: N

    V-TEK IVP GUIDE F. PLTS 3.5 SZ-S L-SHP

    MDR report key: 4818410 · Received June 2, 2015

    Report

    Report Number
    9613350-2015-00632
    Event Type
    Other
    Date Received
    June 2, 2015
    Date of Event
    May 18, 2015
    Report Date
    May 18, 2015
    Manufacturer
    NORMED MEDIZIN-TECHNIK GMBH
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO TREND IDENTIFIED. THE COMPATIBILITY CHECK WAS PERFORMED BY NORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS NOT APPROVED. IT WAS REPORTED THAT THE INSTRUMENT 28.10.140 DOES NOT FIT WITH ADDITION PLATES ANYMORE. IT IS ALLEGED, THAT THE REDESIGNED PLATES ARE WIDER THAN THE USUAL ONES, FOLLOWING IT CANNOT BE USED ANYMORE. IT WAS DETECTED PRIOR TO USE, NO PATIENT INVOLVED IN THIS EVENT. TWO PICTURES WERE SENT. ON THE PICTURES IT CAN BE SEEN THAT THE PLATE DO NIT FIT WITH THE INSTRUMENT. ONLY THE PLATES WERE RETURNED. THE IMPACTOR WAS NOT RETURNED. THE VISUAL EXAMINATION OF THE PLATES DO NOT SHOW ANY ABNORMALITIES. BOTH PLATES LOOK UNUSED. IN 2012, THE V-TEK® IVP SYSTEM WAS DEVELOPED AN INTRODUCED IN TO THE MARKET. IN THE 2ND QUARTER OF 2013, A SYSTEM OPTIMIZATION WITH NEW PRODUCT SPECIFICATIONS WAS PERFORMED, BASED ON EXPERIENCES AND RECOMMENDATION FROM USERS OF THE V-TEK® IVP SYSTEM. THE DESIGN CHANGE WAS PERFORMED FOR PRODUCT IMPROVEMENT AND NOT DUE TO SAFETY REASONS. DUE TO DIFFERENT SPECIFICATION, ONLY PRODUCTS OF THE SAME DESIGN VERSION (2012, 2013) ARE COMPATIBLE. THE SYSTEMS OF 2012, WHICH HAVE BEEN ON THE MARKET, HAVE BEEN REPLACED WITH THE NEW SYSTEM OF 2013 BY THE SALES REP. THE THREE COMPLAINED PLATE IN THE CASE AT HAND ((B)(4)) ARE FROM THE OLD DESIGN, THOUGH THE IMPACTOR IS FROM THE NEW DESIGN, THEREOF WITH DIFFERENT SPECIFICATION AND NOT COMPATIBLE. POSSIBLE CAUSES FOR THE REPORTED EVENT ACCORDING TO RISK MANAGEMENT WORKSHEET FOR A SIMILAR/COMPARABLE DEVICE: LINE R-3.1.2: NON-FITTING OF THE COMPONENTS DUE TO INADEQUATE IMPLANT DESIGN LEADS TO NON-FITTING OF THE COMPONENTS / INSTRUMENT-COMPONENT. LINE R-3.2.1: FAILURE OF SURGERY DUE TO WRONG SELECTION OF COMPONENTS OR USE IN COMBINATION WITH DEVICE OUTSIDE THE SYSTEM. COMPARISON TO INVESTIGATION RESULTS WHETHER IT IS POSSIBLE AND JUSTIFICATION: POSSIBLE: THE AFFECTED PLATES WERE PRODUCED IN QUARTER 3 OF 2012 ACCORDING TO SPECIFICATIONS. IN THE 2ND QUARTER OF 2013 NORMED PERFORMED A DESIGN CHANGE FOR THE PLATES AND INSTRUMENTS WITH NEW SPECIFICATIONS. AS THE IMPACTOR (28.10.140) WAS PRODUCED AFTER THE DESIGN CHANGE AND THE PLATES BEFORE, THE PLATES AND THE IMPACTOR CANNOT FIT TOGETHER. THE AFFECTED PLATES WERE PRODUCED IN QUARTER 3 OF 2012 ACCORDING TO SPECIFICATIONS. IN THE 2ND QUARTER OF 2013 NORMED PERFORMED A DESIGN CHANGE FOR THE PLATES AND INSTRUMENTS WITH NEW SPECIFICATIONS. AS THE IMPACTOR (28.10.140) WAS PRODUCED AFTER THE DESIGN CHANGE AND THE PLATES BEFORE, THE PLATES AND THE IMPACTOR CANNOT FIT TOGETHER. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE COULD IDENTIFY A ROOT CAUSE FOR THE REPORTED EVENT. THE AFFECTED PLATES WERE PRODUCED IN QUARTER 3/2012 ACCORDING TO SPECIFICATIONS. IN THE 2ND QUARTER OF 2013 NORMED PERFORMED A DESIGN CHANGE FOR THE PLATES AND INSTRUMENTS WITH NEW SPECIFICATIONS. AS THE IMPACTOR (28.10.140) WAS PRODUCED AFTER THE DESIGN CHANGE AND THE PLATES BEFORE, THE PLATES AND THE IMPACTOR CANNOT FIT TOGETHER. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. TWO PICTURES WERE PROVIDED. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING STATEMENT WAS REPORTED: "INSTRUMENT 28.10.140 DOESN'T FIT WITH ADDITION PLATES ANYMORE, IT IS ALLEGED, THAT THE REDESIGNED PLATES ARE WIDER THAN THE USUAL ONES, FOLLOWING IT CAN NOT BE USED ANYMORE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353981 V-TEK IVP GUIDE F. PLTS 3.5 SZ-S L-SHP V-TEK IVP GUIDE F. PLTS 3.5 SZ-S L-SHP LXH NORMED MEDIZIN-TECHNIK GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other