BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 HEALIX ADVANCE BR3SUT W/OC

    MDR report key: 9368911 · Received November 25, 2019

    Report

    Report Number
    1221934-2019-59740
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Report Date
    November 18, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705021345
    PMA / PMN Number
    K120078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY ==> ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT THIS WAS AN UNKNOWN PROCEDURE SCHEDULED ON AN UNKNOWN DATE. THE J&J¿S DISTRIBUTOR FOUND HAIR IN THE PACKAGE OF THE ANCHOR (222298) UPON ITS DELIVERY TO THE HOSPITAL. CARDBOARD/PLASTIC PACKAGING WERE RECEIVED, AS RESULT A HAIR WAS FOUND IN OUTER BOX UNDER THE PROTECTIVE PLASTIC. THE CUSTOMER COMPLAINT WAS CONFIRMED. A MANUFACTURE INVESTIGATION WAS PERFORMED IN ORDER TO GET THE ROOT CAUSE FOR THE FAILURE REPORTED BY COSTUMER. THE STERILITY OF THE PRODUCT IS NOT COMPROMISED BECAUSE THE DESIGN OF THE STERILIZATION PROCESS ENSURE STERILITY EVEN IF OUTER PACKAGING IS DIRTY. THE ACTIONS TAKEN TO PREVENT THIS ISSUE IS THAT THE PRODUCT IS IN A SEALED POUCH INSIDE THE BOX WHICH GUARANTEES STERILITY WHATEVER HAPPENS TO THE EXTERIOR PACKAGE. THE CONCLUSION PROVIDED BY THE QUALITY ENGINEER CONTINUOUS IMPROVEMENT WAS THAT HAIR ARRIVED AFTER THE POUCH WAS SEALED AND STERILIZED. AS PER PFMEA AN COMPLAINT REVIEWS, THE OCCURRENCE FOR THIS TYPE OF ISSUE IS BELOW THAN THE MAXIMUM OCCURRENCE ALLOWED FOR THIS KIND OF EFFECT. THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED CAN BE ATTRIBUTED TO AT ANY POINT DURING FINAL PACKAGING SINCE OPERATORS DO NOT WEAR A HYGIENE CAP. THIS IS BECAUSE IT DOES NOT OCCUR IN CONTROLLED ATMOSPHERE BECAUSE THE STERILIZATION PROCESS HAS BEEN DESIGN TO BE SAFE WITHOUT IT. HOWEVER, THIS CANNOT BE CONCLUSIVE DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT/SERIAL NUMBER (B)(6), AND NO NON-CONFORMANCES WERE IDENTIFIED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. SUBSEQUENT FOLLOW-UP WITH THE CUSTOMER, ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PRODUCT WAS SEALED UPON RECEIPT. THE REPORTER ALSO STATED THAT THE DEVICE WAS AVAILABLE FOR RETURN.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS WAS AN UNKNOWN PROCEDURE SCHEDULED ON AN UNKNOWN DATE. THE J&J¿S DISTRIBUTOR FOUND HAIR IN THE PACKAGE OF THE ANCHOR (222298) UPON ITS DELIVERY TO THE HOSPITAL. THE DEVICE WAS THE FIRST USE WHEN THE ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163273 5.5 HEALIX ADVANCE BR3SUT W/OC SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 222298 2L82129 10886705021345

    Patients

    Seq Age Sex Outcome Treatment
    1