BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-HINGE FIXED TIBIAL INSERT SIZE 4/12MM

    MDR report key: 6352745 · Received February 23, 2017

    Report

    Report Number
    3005180920-2017-00060
    Event Type
    Malfunction
    Date Received
    February 23, 2017
    Date of Event
    January 24, 2017
    Report Date
    April 27, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    PMA / PMN Number
    K130299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 30 JANUARY 2017 AND INCLUDES: AFTER OPENING THE PACKAGE, THE SALES AGENT NOTICED THERE WAS NO SCREW IN THE POST. HE VERY CAREFULLY LOOKED THRU THE REST OF THE PACKAGING AND FOAM IN THE BOX, BUT THERE WAS NO SCREW ANYWHERE IN THE PACKAGE OR SURROUNDING PACKAGING. THE OUTER BOX AND THE IMPLANTS IN THE BOX WILL BE SENT BACK TO MEDACTA INTERNATIONAL FOR INVESTIGATION, THE REST OF THE PACKAGING AND FOAM HAD BLOOD ALL OVER IT AND THE NURSE THREW IT INTO THE BIOHAZARD WASTE. BATCH REVIEW PERFORMED ON 21 FEBRUARY 2017. LOT 161842: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 APRIL 2016. EXPIRATION DATE: 2021-03-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017, THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEMS AND COMMENTED AS FOLLOWS: AS REPORTED, THE INLAY SCREW WAS MISSING IN THE PACKAGING AND THE MEDICAL STAFF CONFIRMED THAT THE SCREW DID NOT FELL DOWN DURING THE BLISTER OPENING. THE PACKAGING, WITH THE IMPLANTS, WAS RETURNED OPENED AND THE INLAY SCREW WAS NOT PRESENT. BASED ON THE AVAILABLE INFORMATION AND THE BLISTER RECEIVED, IT IS NOT POSSIBLE TO ESTABLISH A CERTAIN ROOT CAUSE OF THE EVENT AS TO CONFIRM THE LACK OF THE SCREW IN THE PACKAGING. THE TOTAL NUMBER OF THE SCREWS SEMI-FINISHED LOTS, STILL IN OUR WAREHOUSE, WAS VERIFIED AND COMPARED WITH THOSE ALREADY RELEASED, NO ISSUE WAS FOUND. AN OPERATOR INVOLUNTARY HUMAN ERROR AS THE LOSS OF THE SCREW IN THE OPERATOR THEATRE DURING THE SURGERY CAN BE HYPOTHESIZED AS FINAL EVENT ROOT CAUSES.

    Description of Event or Problem · 1

    WHEN THE SURGEON OPENED THE INLAY, HE NOTICED THAT THERE WAS NO SCREW IN THE POST. THE PACKING MATERIAL WAS NOT DAMAGED. THE SURGEON USED A SECONDARY INLAY TO COMPLETE THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137215 GMK-HINGE FIXED TIBIAL INSERT SIZE 4/12MM FIXED TIBIAL INSERT KRO MEDACTA INTERNATIONAL SA 161842

    Patients

    Seq Age Sex Outcome Treatment
    1 Other