BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 HEALIX ADVANCE BR W/OCORD

    MDR report key: 7163373 · Received January 4, 2018

    Report

    Report Number
    1221934-2018-50014
    Event Type
    Malfunction
    Date Received
    January 4, 2018
    Date of Event
    December 6, 2017
    Report Date
    December 8, 2017
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    K120078
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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)(6). (B)(4) - INCOMPLETE. THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED AS IT WAS DISCARDED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. A DHR REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE. 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. DEVICE HISTORY LOT: DHR REVIEW, PART NUMBER: 222297, LOT NUMBER: L563140, SUPPLIER LOT NUMBER: N/A, RELEASE TO WAREHOUSE DATE: 10.11.2017, MANUFACTURING DATE: 10.11.2017, EXPIRATION DATE: 08.31.2020, SUPPLIER: N/A. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. UDI: (B)(4).

    Description of Event or Problem · 1

    HEALIX ADVANCE BR ANCHORW/ORTHOCORD REF. 222297 ¿ SUTURE SNAPPED LOT.NO.L563140. HEALIX ADVANCE ¿ KNOTLESS BR ANCHOR REF. 222331 ¿ SUTURE NOT ATTACHED TO ANCHOR SO COULDN¿T USE LOT.NO L336169.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9529 5.5 HEALIX ADVANCE BR W/OCORD SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK L563140

    Patients

    Seq Age Sex Outcome Treatment
    1