BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEATER - POSITIONER - ALIGNER

    MDR report key: 6095787 · Received November 11, 2016

    Report

    Report Number
    3008021110-2016-00042
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    JDI
    PMA / PMN Number
    K112158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CHECK OF THE DHR OF THE LOT # INVOLVED (15AG0UY) DID NOT SHOW ANY PRE-EXISTING ANOMALY ON THE 30 IMPACTORS MANUFACTURED WITH THIS LOT #, AND AVAILABLE ON THE MARKET SINCE NOVEMBER 2015. THERE WAS NO OTHER COMPLAINT REPORTED ON THIS LOT#. WE CHECKED EVEN THE MANUFACTURING CHARTS OF THE DELTA TT ACETABULAR CUP (MODEL # 5552.15.560, LOT# 1601991) INVOLVED IN THIS EVENT: NO PRE-EXISTING ANOMALY ON THE (B)(4) MANUFACTURED WITH THIS LOT#. AFTER RECEIVING THE IMPACTOR INVOLVED IN THE ISSUE, WE PERFORMED A DIMENSIONAL/FUNCTIONAL CHECK ON ITS MALE THREAD; THIS CHECK CONFIRMED THE FULL FUNCTIONALITY OF THE THREAD. BASED ON THE ABOVE ANALYSIS, THERE ARE NO DEFECTS ON THE INSTRUMENT. THE LIKELY CAUSE OF THIS INTRA-OPERATIVE ISSUE IS THE EXCESSIVE STRENGTH APPLIED BY THE SURGEON WHEN SCREWING THE IMPACTOR INTO THE CUP AND/OR WHEN IMPACTING THE CUP INTO THE ACETABULUM. THIS COULD HAVE PREVENTED AN EASY UNSCREWING OF THE IMPACTOR FROM THE CUP DURING THE SURGERY. ADDITIONALLY, THE DELTA SYSTEM SURGICAL TECHNIQUE SPECIFIES THAT THE IMPACTOR INVOLVED (9057.20.555) MUST NOT BE USED WITH DEFINITIVE CUPS, BUT ONLY WITH TRIAL CUPS. A WRENCH IS PROVIDED SPECIFICALLY FOR THE IMPACTION OF THE DEFINITIVE CUP: THE WRENCH IS TO BE USED IN COMBINATION WITH MODULAR ADAPTORS, THAT HELP PREVENTING THE DEFORMATION OF THE CUP DURING IMPACTION. ACCORDING TO LIMACORPORATE POST MARKET SURVEILLANCE DATA, THERE WERE A TOTAL OF 3 CASES WHERE AN IMPACTOR WITH PRODUCT CODE 9057.20.555 WAS INVOLVED IN SUCH AN INTRA-OP ISSUE (SEIZURE BETWEEN IMPACTOR AND CUP), ON A TOTAL OF ABOUT 1650 IMPACTORS MANUFACTURED WITH THIS PRODUCT CODE (OCCURRENCE RATE OF 0.18%). 3 DIFFERENT LOT # OF IMPACTORS ARE INVOLVED, INDICATING THAT THERE'S NOT A "LOT # ISSUE". AS ALL THE 3 SIMILAR EVENTS INVOLVED THE (B)(4) MARKET, THE USERS INVOLVED ARE BEING INFORMED ON THE IMPORTANCE THAT SURGEONS AVOID USING THE IMPACTORS 9057.20.555 WITH DEFINITIVE CUPS, AS ALREADY REPORTED IN THE DELTA SURGICAL TECHNIQUE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    INTRA-OPERATIVE ISSUE INVOLVING A CUP IMPACTOR (MODEL # 9057.20.555, LOT # 15AG0UY). AFTER THAT DEFINITIVE CUP WAS IMPACTED INTO THE ACETABULUM, IT WAS VERY DIFFICULT TO UNSCREW THE IMPACTOR (MALE THREAD) FROM THE CUP (FEMALE THREAD). THE IMPACTOR WAS DETACHED FROM THE CUP BY MEANS OF A PLIER AND THE DEFINITIVE CUP WAS LEFT IN PLACE. SURGERY TIME EXTENDED BY 15 MINUTES. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE EFFECT FOR THE PATIENT. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748951 BEATER - POSITIONER - ALIGNER IMPACTOR - POSITIONER - ALIGNER JDI LIMACORPORATE S.P.A. 9057.20.555 15AG0UY

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown