BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOSPHERE IMPACTOR-EXTRACTOR

    MDR report key: 7081994 · Received December 5, 2017

    Report

    Report Number
    3008021110-2017-00111
    Event Type
    Malfunction
    Date Received
    December 5, 2017
    Date of Event
    November 7, 2017
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K110598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WE CHECKED THE MANUFACTURING CHART RELATED TO THE LOT# OF GLENOSPHERE IMPACTOR INVOLVED, WITHOUT DETECTING ANY ANOMALY. NO OTHER COMPLAINTS RECEIVED ON THIS LOT#. WE ALSO RECEIVED THE IMPACTOR AND GLENOSPHERE INVOLVED. WITH SOME EFFORT WE COULD UNSCREW THE MALE THREAD OF THE IMPACTOR FROM THE FEMALE THREAD OF THE CONNECTOR (FIXED TO THE GLENOSPHERE) AND, AFTER THIS OPERATION, WE COULD CHECK THAT THE FUNCTIONALITY OF BOTH MALE AND FEMALE THREAD IS OK. ACCORDING TO THE ABOVE INVESTIGATION, THE LIKELY CAUSE FOR THIS SEIZURE WAS AN OVER-TIGHTENING OF THE IMPACTOR INTO THE GLENOSPHERE DURING THE SURGERY. THE PRODUCTS INVOLVED WERE (AND ARE) FULLY FUNCTIONAL. WE ARE AWARE OF A TOTAL OF 3 SIMILAR CASES INVOLVING 3 DIFFERENT LOT# OF GLENOSPHERE IMPACTORS WITH MODEL # 9013.74.141, ON A TOTAL OF 15.590 ESTIMATED USES OF THESE INSTRUMENTS, FOR AN OCCURRENCE RATE OF 0.019%. NO CORRECTIVE ACTIONS PLANNED. LIMACORPORATE WILL KEEP MONITORED THE MARKET.

    Description of Event or Problem · 0

    INTRA-OP ISSUE EXPERIENCED DURING A SHOULDER SURGERY (CONVERSION FROM SMR ANATOMIC TO SMR REVERSE) PERFORMED ON (B)(6) 2017: SEIZURE BETWEEN THE GLENOSPHERE IMPACTOR (MODEL # 9013.74.141, LOT# 16AA00N) AND GLENOSPHERE. ACCORDING TO THE INFO REPORTED, SURGEON WAS IMPACTING THE DIA.40MM GLENOSPHERE. SURGEON WAS UNABLE TO ENGAGE THE LOCKING SCREW TO FIX THE COUPLING BETWEEN GLENOSPHERE AND METAL BACK GLENOID, BECAUSE BONE HAD FORMED OVER TIME IN THE HOLE OF THE METAL BACK. HE THEN REMOVED THE GLENOSPHERE TO CLEAN HOLE OF THE METAL BACK BUT DOING SO, GLENOSPHERE GOT STUCK ON THE INTRODUCER. INSTRUMENT WAS VERY LIKELY OVER TIGHTENED WHEN THE GLENOSPHERE WAS EXTRACTED. NO IMPACT ON THE PATIENT AND NO PROLONGED SURGERY TIME REPORTED (SEIZURE BETWEEN INSTRUMENT AND GLENOSPHERE WAS IDENTIFIED OFF TABLE). SURGERY SUCCESSFULLY CONCLUDED BY USING A DIA.44 MM GLENOSPHERE AND ANOTHER GLENOSPHERE IMPACTOR FROM A SECOND SET AVAILABLE AT THE HOSPITAL. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    NO OTHER COMPLAINTS RECEIVED ON THE SAME LOT# (16AA00N). WE WILL SUBMIT A FINAL EMDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    SMR GLENOSPHERE DIA.40MM - GLENOSPHERE INTRODUCER SEIZURE EXPERIENCED DURING A SHOULDER SURGERY PERFORMED ON (B)(6) 2017. ACCORDING TO THE INFO REPORTED, SURGEON WAS IMPACTING A 40MM GLENOSPHERE WHEN WAS UNABLE TO ENGAGE THE LOCKING SCREW. GLENOSPHERE WAS THEN REMOVED BUT DOING SO, IT GOT STUCK ON THE INTRODUCER. INSTRUMENT WAS OVER TIGHTENED WHEN THE GLENOSPHERE WAS EXTRACTED. NO IMPACT ON THE PATIENT AND NO PROLONGED SURGERY TIME REPORTED. SURGERY SUCCESSFULLY CONCLUDED BY USING A 44 MM GLENOSPHERE AND A SMR INTRODUCER FROM A SECOND SET AVAILABLE AT THE HOSPITAL. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861046 GLENOSPHERE IMPACTOR-EXTRACTOR GLENOSPHERE IMPACTOR-EXTRACTOR KWS LIMACORPORATE S.P.A. 9013.74.141 16AA00N

    Patients

    Seq Age Sex Outcome Treatment
    1