BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMR PROSTHESIS INTRODUCER

    MDR report key: 4278609 · Received November 26, 2014

    Report

    Report Number
    3008021110-2014-00022
    Event Type
    Malfunction
    Date Received
    November 26, 2014
    Date of Event
    September 24, 2014
    Report Date
    October 30, 2014
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    PMA / PMN Number
    K100858
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE CHECKED THE DHR OF THE BATCH INVOLVED, WITHOUT FINDING ANY ANOMALY IN THE DIMENSIONS AND THE RAW MATERIAL CERTIFICATE (AISI 630 H900 HEAT TREATED) OF THE INSTRUMENTS. A TOTAL OF 26 INTRODUCERS HAVE BEEN MANUFACTURED WITH THE LOT # 201106631, AND WE RECEIVED NO OTHER SIGNALINGS ON THIS LOT NUMBER. WE DON'T KNOW HOW MANY TIMES THE INTRODUCER WAS USED; AS IT WAS MANUFACTURED IN 2011, WE MAY SUPPOSE THAT THE BREAKAGE OF THE LUG HAPPENED AFTER A CERTAIN NUMBER OF USES OF THE INSTRUMENT. WE ALSO RECEIVED THE BROKEN INTRODUCER, AND WE REPEATED THE MEASURE OF THE HARDNESS ON ITS SURFACE NEAR TO THE BROKEN LUG (A HARDNESS OF 47 HRC HAD BEEN DETECTED ON THE INSTRUMENT BEFORE PLACING IT ON THE MARKET). THE FURTHER HARDNESS TEST PERFORMED ON THE BROKEN INSTRUMENT GAVE A VALUE OF 45 HRC, WHICH IS FULLY COMPLIANT WITH THOSE RECOMMENDED BY THE ASTM A564 (MINIMUM ALLOWED 40 HRC) FOR THE AISI 630 H900 HEAT TREATED. SUMMARIZING, NO PRE-EXISTING DEFECTS ON THE INTRODUCER WERE DETECTED. WE BELIEVE THAT THE INTRA-OP ISSUE MAY HAVE BEEN CAUSED BY AN UNEXPECTED STRESS APPLIED AT THE BASE OF THE LUGS DURING THE IMPACTION OF THE SMR PROSTHESIS INTO THE HUMERAL CANAL. THERE ARE NO CONSEQUENCES FOR PATIENT HEALTH DUE TO THESE INTRA-OPERATIVE BREAKAGES. HOWEVER, BEFORE BECOMING AWARE OF THIS EVENT, IN 2013 LIMACORPORATE SLIGHTLY MODIFIED THE GEOMETRY OF THE CONNECTION SURFACE OF THE INSTRUMENT WITH THE HUMERAL BODY. BASICALLY, THE IMPROVEMENT CONSISTS IN ADDING MATERIAL AT THE BASE OF THE LUGS, THUS OBTAINING A REDUCTION IN THE CANTILEVER PART. THIS ADJUSTMENT INCREASES THE MECHANICAL STRENGTH OF THE LUGS, AND PROLONGS THE SERVICE LIFE OF THE INTRODUCERS. THE INSTRUMENT INVOLVED IN THIS CASE WAS MANUFACTURED IN 2011, BEFORE THE IMPROVEMENT DESCRIBED ABOVE. NO BREAKAGES OF THE IMPROVED INSTRUMENT HAVE BEEN REPORTED UNTIL NOW. THE IMPROVED INSTRUMENTS WILL GRADUALLY AND COMPLETELY REPLACE THE PREVIOUS VERSION ON THE MARKET.

    Additional Manufacturer Narrative · 1

    WE CHECKED THE DHR OF THE BATCH INVOLVED, WITHOUT FINDING ANY ANOMALY IN THE DIMENSIONS AND THE RAW MATERIAL CERTIFICATE (B)(6) OF THE INSTRUMENTS. A TOTAL OF (B)(4) INTRODUCERS HAVE BEEN MANUFACTURED WITH THE LOT # 201106631, AND WE RECEIVED NO OTHER SIGNALINGS ON THIS LOT #. WE WILL RECEIVE THE BROKEN INSTRUMENT AND ANALYZE IT, THEN WE WILL SUBMIT A FOLLOW-UP EMDR ON THIS INTRA-OPERATIVE BREAKAGE. THERE ARE NO CONSEQUENCES FOR PATIENT HEALTH DUE TO THESE INTRA-OPERATIVE BREAKAGES. HOWEVER, BEFORE BECOMING AWARE OF THIS EVENT, IN 2013 LIMA CORPORATE SLIGHTLY MODIFIED THE GEOMETRY OF THE CONNECTION SURFACE OF THE INSTRUMENT WITH THE HUMERAL BODY. BASICALLY, THE IMPROVEMENT CONSISTS IN ADDING MATERIAL AT THE BASE OF THE LUGS, THUS OBTAINING A REDUCTION IN THE CANTILEVER PART. THIS ADJUSTMENT INCREASES THE MECHANICAL STRENGTH OF THE LUGS, AND PROLONGS THE SERVICE LIFE OF THE INTRODUCERS. THE INSTRUMENT INVOLVED IN THIS CASE WAS MANUFACTURED IN 2011, BEFORE THE IMPROVEMENT DESCRIBED ABOVE. DEVICE NOT YET RETURNED.

    Description of Event or Problem · 1

    ONE OF THE 3 LUGS OF THE SMR PROSTHESIS INTRODUCER BROKE OFF WHILST BEING USED TO IMPACT THE IMPLANT (COUPLED HUMERAL STEM + HUMERAL BODY) INTO THE HUMERAL CANAL. IT DID NOT AFFECT THE PROCEDURE AS THE INTRODUCER HAD STILL 2 LUGS ATTACHED OUT OF THE 3, SO THE SURGEON COULD USE THE INTRODUCER WITH NO ISSUES. THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    ONE OF THE 3 LUGS OF THE SMR PROSTHESIS INTRODUCER BROKE OFF WHILST BEING USED TO IMPACT THE IMPLANT (COUPLED HUMERAL STEM + HUMERAL BODY) INTO THE HUMERAL CANAL. IT DID NOT AFFECT THE PROCEDURE AS THE INTRODUCER HAD STILL 2 LUGS ATTACHED OUT OF THE 3, SO THE SURGEON COULD USE THE INTRODUCER WITH NO ISSUES. THE EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768273 SMR PROSTHESIS INTRODUCER KWT, HSD KWT LIMACORPORATE S.P.A. 9013.02.320 201106631

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization