BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WRENCH FOR DELTA CUPS

    MDR report key: 4344718 · Received December 19, 2014

    Report

    Report Number
    3008021110-2014-00026
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    July 25, 2014
    Report Date
    November 24, 2014
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    MBL
    PMA / PMN Number
    K112898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE CHECKED THE DHR OF THE LOT # INVOLVED, WITHOUT FINDING ANY PRE-EXISTING ANOMALY ON THE INSTRUMENTS. WE HAVE RECEIVED THE TWO INSTRUMENTS INVOLVED AND WE ARE NOW INVESTIGATING TO DEFINE THE CAUSES OF THE BREAKAGES. WE WILL SEND A FOLLOW-UP MDR AT THE END OF THE INVESTIGATION. DEVICE UNDER EVALUATION.

    Additional Manufacturer Narrative · 1

    WE CHECKED THE MANUFACTURING CHARTS OF THE TWO LOT # INVOLVED, WITHOUT FINDING ANY PRE-EXISTING ANOMALY ON THE INSTRUMENTS. WE HAVE RECEIVED THE TWO INSTRUMENTS AND CONFIRMED THE BREAKAGE OF THE BLUE RADEL BUSHINGS. WE THEN TRIED TO REPRODUCE THIS FAILURE MODE BY TESTING, ACCORDING TO THE DELTA SURGICAL TECHNIQUE, AN UNUSED IMPACTOR WITH UNUSED INTACT BUSHING AT DIFFERENT STANDARD STERILIZATION CYCLES (STEAM STERILIZATION WITH MAXIMUM TEMPERATURE 134°C ); BY THE TEST PERFORMED, WE DETECTED THAT THE BREAKAGE OF THE BLUE RADEL BUSHING MAY OCCUR AS A COMBINATION OF THE REPEATED STERILIZATION CYCLES AND THE STRESSES CAUSED BY THE REPEATED IMPACTIONS DURING SURGERY. THESE ARE THE FIRSTS SIMILAR EVENTS REPORTED. ANYWAY, LIMACORPORATE HAS DESIGNED SOME NEW PROTOTYPES OF BUSHINGS MADE FROM DIFFERENT GEOMETRY AND MATERIALS (BLUE RADEL AND GREY PROPYLUX). BY THE PRELIMINARY COMPARATIVE TESTS PERFORMED, SOME OF THE NEW PROTOTYPES OF BUSHINGS SHOWED AN IMPROVEMENT OF THE MECHANICAL RESISTANCE IF COMPARED WITH THE "CURRENT" BUSHINGS. LIMACORPORATE IS GOING TO PERFORM FURTHER INTERNAL TESTS TO CHOOSE THE BEST SOLUTION OF BUSHING, THEN THE NEW WRENCHES FOR DELTA CUP WITH THE BEST SOLUTION OF BUSHING WILL BE PLACED ON THE MARKET.

    Description of Event or Problem · 1

    DURING TWO DIFFERENT SURGERIES, THE BLUE BUSHING (MADE FROM RADEL) OF TWO WRENCHES FOR DELTA CUPS (MODEL # 9055.51.015) BROKE WHILE HAMMERING THE CUP INTO THE ACETABULAR BONE. WE HAVE NOT BEEN REPORTED OF ANY ISSUE FOR THE PATIENTS DUE TO THESE INTRA-OP EVENTS. THE EVENTS OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    DURING TWO DIFFERENT SURGERIES, THE BLUE BUSHING (MADE FROM RADEL) OF TWO WRENCHES FOR DELTA CUPS (MODEL # 9055.51.015) BROKE WHILE HAMMERING THE CUP INTO THE ACETABULAR BONE. WE HAVE NOT BEEN REPORTED OF ANY ISSUE DUE TO THESE INTRA-OP EVENTS. THE EVENTS OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837198 WRENCH FOR DELTA CUPS LPH, MBL MBL LIMACORPORATE S.P.A. 9055.51.015 201317152

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization