BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOSPHERE IMPACTOR-EXTRACTOR

    MDR report key: 15457439 · Received September 20, 2022

    Report

    Report Number
    3008021110-2022-00084
    Event Type
    Malfunction
    Date Received
    September 20, 2022
    Date of Event
    September 14, 2022
    Report Date
    January 20, 2023
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K110598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #1212102, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS MANUFACTURED WITH THE SAME LOT #. FURTHER CHECKING THE MANUFACTURING CHARTS OF THE 40MM GLENOSPHERE BELONGING TO LOT #2213168 AND OF THE +4MM LATERALIZING SMALL-R CONNECTOR BELONGING TO LOT #2208402, NO PRE-EXISTING ANOMALY WAS FOUND ON THE ITEMS MANUFACTURED WITH THE SAME LOT #S. THUS, WE EXCLUDE ANY ANOMALY ON THE IMPLANTABLE DEVICES WHICH COULD HAVE LED TO THE REPORTED ISSUE. A PICTURE OF THE INVOLVED INSTRUMENT WAS SHARED, CONFIRMING THAT GLENOSPHERE IMPACTOR-EXTRACTOR BROKE AT THE LEVEL OF THE THREADED DISTAL END. HOWEVER, THE INSTRUMENT INVOLVED IN THE EVENT WAS NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS AS IT WAS THROWN AWAY BY THE HOSPITAL. WE ARE NOT ABLE TO FURTHER INVESTIGATE THE EVENT. THE APPLICABLE SURGICAL TECHNIQUE FOR SHOULDER PROCEDURES POINTS OUT THAT "THE THREADED TIP OF THE INSTRUMENT MUST BE COMPLETELY TIGHTENED INTO THE APEX HOLE OF THE GLENOSPHERE BEFORE TAPPING IN THE MORSE TAPER COUPLING WITH THE MALLET; THE TIGHTENING OF THE INSTRUMENT MUST BE STOPPED ONLY WHEN THE SURGEON FEELS HIGH RESISTANCE TO CONTINUE THE TIGHTENING ACTION". IN ADDITION, IT IS STATED THAT "WHEN IMPACTING THE GLENOSPHERE, THE MALLET MUST BE USED ALONG THE DIRECTION (AXIS) OF THE SMR GLENOSPHERE IMPACTOR-EXTRACTOR, AVOIDING AS MUCH AS POSSIBLE THE ONSET OF UNEXPECTED MULTI-AXIAL FORCES DURING IMPACTION. IF BOTH OF THE ABOVE CONDITIONS ARE NOT VERIFIED, THE THREADED SECTION OF THE INSTRUMENTS IS SUBJECTED TO INCREASED UNEXPECTED STRESSES THAT CAN LEAD TO ITS BREAKAGE". THE INSTRUMENT WAS MANUFACTURED IN 2012, THUS IT HAS BEEN USED MULTIPLE TIMES BEFORE THREAD BREAKAGE OCCURRED. WE COULD SUPPOSE THAT THE BREAKAGE OF THE THREAD MIGHT HAVE OCCURRED DUE TO UNCOMPLETE THREADING OF THE INSTRUMENT INTO THE GLENOSPHERE. INDEED, IF THE INSTRUMENT IS NOT THREADED UP TO STOP, UNEXPECTED STRESSES COULD APPLY ON ITS THREAD DURING SURGERIES, LEADING TO BREAKAGE. UNPROPER USES OF THE INSTRUMENT OVERTIME MIGHT HAVE TRIGGERED THE BREAKAGE OF THE DISTAL THREADED SECTION. AS COMMENTED BY THE SURGEON, WEAR AND TEAR OF THE DEVICE OVER TIME CONTRIBUTED TO THE EVENT. CONSIDERING THAT: · CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOT #1212102; · THE INSTRUMENT WAS MANUFACTURED IN 2012, SERVING THE MARKET FOR ABOUT 10 YEARS; · ACCORDING TO THE SURGEON REMARKS, THE INSTRUMENT IS SUBJECT TO WEAR AND TEAR AS A CONSEQUENCE OF ITS MULTIPLE USES OVER THE YEARS; · ACCORDING TO THE RECEIVED INFORMATION, THE INSTRUMENT WAS USED ACCORDING TO THE SURGICAL TECHNIQUE; WE CANNOT DEFINE WITH CERTAINTY THE ROOT CAUSE OF THE EVENT, HOWEVER WE CAN HYPOTHESIZE THAT UNEXPECTED STRESSES HAVE BEEN APPLIED TO THE THREAD DURING SURGERIES, EVENTUALLY LEADING TO BREAKAGE. PMS DATA ACCORDING TO OUR PMS DATA, WE CAN ESTIMATE THE BREAKAGE RATE OF THE INSTRUMENT 9013.74.140 TO BE (B)(4)% (WW). PLEASE NOTE THAT THIS OCCURRENCE RATE IS OVERESTIMATED BECAUSE IT DOES NOT CONSIDER THE REUSE OF THE INSTRUMENTS BUT ONLY THE TOTAL NUMBER OF PIECES MANUFACTURED. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS ARE REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE CONTINUES MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A COMBINED INITIAL-FINAL REPORT

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #1212102, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS MANUFACTURED WITH THE SAME LOT #. WE SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    DURING A SHOULDER PRIMARY SURGERY PERFORMED ON (B)(6) 2022, THE DISTAL END OF THE GLENOSPHERE IMPACTOR-EXTRACTOR (PRODUCT CODE 9013.74.140, LOT #1212102) SNAPPED AT THE THREAD LEVEL AFTER DEVICE IMPACTION INTO THE METALBACK, PRECISELY WHEN THE SURGEON WAS TESTING THE STABILITY OF THE CONSTRUCT BY MOVING THE INSERTER BY HAND. IT WAS REPORTED THAT THE INSTRUMENT WAS COMPLETELY THREADED INTO THE GLENOSPHERE AND IMPACTED AXIALLY INTO THE SMALL R METALBACK ACCORDING TO THE SURGICAL TECHNIQUE. AS THE DISTAL END OF THE INSERTER SNAPPED AT THE THREAD LEVEL THUS BLOCKING THE APEX HOLE OF THE GLENOSPHERE, IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO REMOVE THE 40MM GLENOSPHERE (LOT #2213168) AND THE +4MM LATERALIZING SMALL-R CONNECTOR (LOT #2208402) WITH MULTIPLE TOOLS, EVENTUALLY REMOVING IT. NEW COMPONENTS WERE IMPLANTED. IT WAS REPORTED THAT THE SURGEON WAS SATISFIED WITH THE FINAL IMPLANT. ACCORDING TO THE SURGEON REMARKS, THE INSTRUMENT UNDERPERFORMED DUE TO ITS AGE. SURGERY GOT PROLONGED OF 20 MINUTES. EVENT HAPPENED IN AUSTRALIA.

    Description of Event or Problem · 0

    DURING A SHOULDER PRIMARY SURGERY PERFORMED ON (B)(6) 2022, THE DISTAL END OF THE GLENOSPHERE IMPACTOR-EXTRACTOR (PRODUCT CODE 9013.74.140, LOT #1212102) SNAPPED AT THE THREAD LEVEL WHEN THE SURGEON WAS TESTING THE STABILITY OF THE CONSTRUCT BY MOVING THE INSERTER BY HAND. IT WAS REPORTED THAT THE INSTRUMENT WAS SCREWED INTO THE 40MM GLENOSPHERE AND IMPACTED INTO THE SMALL R MB ACCORDING TO THE SURGICAL TECHNIQUE. ACCORDING TO THE COMPLAINT SOURCE, THE SURGEON ATTEMPTED TO REMOVE THE GLENOSPHERE/+4MM LATERALISING SMALL-R CONNECTOR PIN COMBINATION WITH MULTIPLE TOOLS, EVENTUALLY REMOVING IT. NEW COMPONENTS WERE IMPLANTED. IT WAS REPORTED THAT THE SURGEON WAS SATISFIED WITH THE FINAL IMPLANT. SURGERY GOT PROLONGED OF 20 MINUTES. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2698971 GLENOSPHERE IMPACTOR-EXTRACTOR GLENOSPHERE IMPACTOR-EXTRACTOR KWS LIMACORPORATE S.P.A. 9013.74.140 1212102

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other