BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALIX AV PK 5.5 TAPE WHT/BLUE

    MDR report key: 7994713 · Received October 23, 2018

    Report

    Report Number
    1221934-2018-55023
    Event Type
    Injury
    Date Received
    October 23, 2018
    Date of Event
    September 28, 2018
    Report Date
    September 28, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    MBI
    UDI-DI
    10886705028009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. EVALUATION STATEMENT: THE COMPLAINT DEVICE WAS DISCARDED BY THE CUSTOMER THEREFORE, DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION. NO PICTURES WERE PROVIDED. THIS COMPLAINT IS NOT CONFIRMED. AS REPORTED THEIR HEALIX ADVANCE ANCHOR BROKE AT THE TIP. NO FRAGMENTS WERE LEFT IN THE PATIENT. NO FURTHER INFORMATION REGARDING THE PROCEDURE OR THE DEVICE USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PART 222366 LOT L946815 COMBINATION AND NO NONCONFORMANCES WERE IDENTIFIED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. 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. UDI: (B)(4). THE EXPIRATION DATE IS NOT CURRENTLY AVAILABLE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM AFFILIATE ON 04-OCTOBER-2018: THE ANCHOR WAS NOT LEFT IN SITU. IT IS BELIEVED ANOTHER HOLE WAS MADE FOR THE ANCHOR. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4)-INCOMPLETE. THE EXP DATE IS CURRENTLY UNAVAILABLE. 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 BY THE AFFILIATE IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE HEALIX ADVANCE ANCHOR DEVICE BROKE AT THE TIP. IT WAS REPORTED THAT THE PATIENT HAD A HARD BONE, AND THE INSERTION WAS SLIGHTLY OFF AXIS. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE AS ANOTHER SAME LIKE PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834395 HEALIX AV PK 5.5 TAPE WHT/BLUE SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE MBI MEDOS INTERNATIONAL SàRL L946815 10886705028009

    Patients

    Seq Age Sex Outcome Treatment
    1 Other