BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMR TRIAL HUMERAL HEAD

    MDR report key: 4867909 · Received June 25, 2015

    Report

    Report Number
    3008021110-2015-00027
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Date of Event
    May 22, 2015
    Report Date
    June 3, 2015
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    KWT
    PMA / PMN Number
    K100858
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INCLUDING THIS CASE, A TOTAL OF TWO (2) COMPLAINTS (COMPLAINT # (B)(4)) WERE RECEIVED BY LIMACORPORATE REGARDING DIFFICULTY TO ASSEMBLE THE TRIAL HUMERAL HEAD TO THE TRIAL ADAPTOR DURING SURGERY. BOTH EVENTS CAUSED A SLIGHT DELAY IN SURGERY BUT NO PATIENT INJURY. THE SECOND COMPLAINT WAS REPORTED AS INITIAL MDR; A FINAL MDR WILL BE SUBMITTED ALSO FOR THAT CASE. THE COMPLAINT INVESTIGATIONS OF THESE TWO (2) EVENTS REVEALED THAT THREE (3) BATCHES OF TRIAL HUMERAL HEADS AND TWO (2) BATCHES OF TRIAL ADAPTORS HAD BEEN MANUFACTURED OUT OF SPECIFICATION BY THE SUPPLIER, ORCHID ORTHOPEDIC SOLUTIONS, LLC. FOLLOWING THE COMPLAINT INVESTIGATION, LIMACORPORATE DECIDED TO REMOVE ANY AND ALL AFFECTED PARTS FROM THESE BATCHES FROM THE MARKET. THE RECALL ACTION WAS COMMUNICATED TO THE FDA ON THE 08/14/2015 AND IS NOW COMPLETED; ON THE 02/26/2016 THE FDA HAS NOTIFIED LIMA IN WRITING THAT THE AGENCY NOW CONSIDERS THE RECALL CLOSED. CAPAS: FIVE (5) NON-CONFORMITIES (NC),ONE FOR EACH OF THE AFFECTED BATCHES INVOLVED, WERE ISSUED TO THE SUPPLIER, (B)(4), BY LIMACORPORATE. THE LIMACORPORATE INTERNAL ROOT CAUSE ANALYSIS IDENTIFIED A POTENTIAL CAUSE IN THE INCOMING INSPECTIONS PROCESS. IT'S LIKELY THE OPERATOR DID NOT PERFORM CORRECTLY ALL THE CHECKS. IN DETAIL, THE FUNCTIONALITY TEST WITH THE PROPER GAUGES WAS PERFORMED ON A SAMPLE BASE INSTEAD OF ON ALL THE DEVICES. THIS DECISION WAS TAKEN AUTONOMOUSLY BY THE OPERATOR DUE TO THE AVAILABILITY OF THE DIMENSIONAL RECORDS ON THE CRITICAL FIGURES PERFORMED ON ALL THE PIECES BY THE SUPPLIER. SINCE THE DRAWINGS ALREADY CONTAIN THE INFORMATION FOR THE CONTROL OF CRITICAL DIMENSIONS, THE CALIBRATED GAUGES ARE AVAILABLE AND THE SOP FOR INCOMING INSPECTIONS SPECIFIES THE NEED OF 100% CONTROL OF CRITICAL DIMENSIONS, THE QUALITY DOCUMENTATION CAN BE CONSIDERED ENOUGH DETAILED. SINCE THE CAUSE IS RELATED TO AN IMPROPER BEHAVIOUR OF THE OPERATOR, THE LIMACORPORATE CORRECTIVE ACTION HAS BEEN THAT OF PERFORMING A SPECIFIC TRAINING TO SENSITIZE OPERATORS TO WORK STRICTLY ACCORDING TO SOPS. NO OTHER SIMILAR COMPLAINTS WERE REPORTED. LIMACORPORATE WILL CONTINUE TO MONITOR THE MARKET TO PROMPTLY DETECT A POSSIBLE RECURRENCE OF SIMILAR ISSUES.

    Additional Manufacturer Narrative · 1

    A PRELIMINARY INVESTIGATION PERFORMED IN LIMA US INDICATES THAT THE CAUSE OF THE INTRA-OP ISSUE IS TO BE RELATED TO THE TRIAL HEADS ONLY, AS OTHER TRIAL ADAPTERS (FROM ANOTHER SET), WHICH WORK OK WITH THE TRIAL HUMERAL HEADS OF THEIR OWN SET, DO NOT WORK OK WITH THE TRIAL HUMERAL HEADS INVOLVED THE ISSUE. THE CHECK OF THE MANUFACTURING CHARTS OF THE TRIAL HEADS INVOLVED DID NOT SHOW ANY PRE-EXISTING ANOMALY. NO OTHER COMPLAINTS WERE RECEIVED ON THE LOT # INVOLVED. WE WILL RECEIVE THE TRIAL HEADS INVOLVED AND ANALYZE THEM. DEVICE NOT YET RETURNED.

    Description of Event or Problem · 1

    DURING SURGERY, THE ECCENTRIC TRIAL ADAPTERS WOULD NOT, WITHOUT HUGE EFFORT, GO INTO HEAD TRIALS. AFTER MUCH EFFORT, THE SURGEON WAS ABLE TO GET THEM TO SEAT AT LEAST PARTIALLY. THEY STUCK UP PAST FLUSH BY ABOUT 1MM. THIS ISSUE ADDED APPROXIMATELY 15-20 MINUTES TO THE SURGERY. NO OTHER CONSEQUENCES REPORTED FOR THE PATIENT. THE EVENT OCCURRED IN THE US.

    Description of Event or Problem · 1

    DURING SURGERY, THE ECCENTRIC TRIAL ADAPTERS WOULD NOT FIT INTO THE TRIAL HEAD. AFTER SEVERAL ATTEMPTS, THE SURGEON WAS ABLE TO GET THE TRAIL ADAPTER TO SEAT PARTIALLY INTO THE TRIAL HEAD. THIS ISSUE ADDED APPROXIMATELY 15-20 MINUTES TO THE SURGERY. NO OTHER CONSEQUENCES REPORTED FOR THE PATIENT. THE EVENT OCCURRED IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412691 SMR TRIAL HUMERAL HEAD SMR TRIAL HUMERAL HEAD KWT LIMACORPORATE S.P.A 9013.22.425 2014AA234

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization