BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5 HEALIX ADVANCE PEEK ANCHOR WITH ORTHOCORD

    MDR report key: 7773884 · Received August 10, 2018

    Report

    Report Number
    1221934-2018-54467
    Event Type
    Malfunction
    Date Received
    August 10, 2018
    Date of Event
    July 15, 2018
    Report Date
    July 15, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    UDI-DI
    10886705021390
    PMA / PMN Number
    K120449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE DEVICE IS NOT BEING RETURNED. THE DEVICE IS NOT AVAILABLE FOR PHYSICAL EVALUATION AND HENCE THIS COMPLAINT CANNOT BE CONFIRMED. NO NONCONFORMANCE WERE IDENTIFIED FOR THIS PART/LOT NUMBER COMBINATION. A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO COMPLAINTS OF ANY SORT FOR THIS DEVICE'S SERIAL NUMBER. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. 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. (B)(4). THE EXPIRATION DATE IS NOT CURRENTLY AVAILABLE.

    Additional Manufacturer Narrative · 0

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE DEVICE IS NOT BEING RETURNED. THE DEVICE IS NOT AVAILABLE FOR PHYSICAL EVALUATION AND HENCE THIS COMPLAINT CANNOT BE CONFIRMED. NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PART -LOT NUMBER COMBINATION. A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO COMPLAINTS OF ANY SORT FOR THIS DEVICE'S SERIAL NUMBER. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. 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. (B)(4). THE EXPIRATION DATE IS NOT CURRENTLY AVAILABLE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM AFFILIATE ON 05OCTOBER2018: IT WAS NOTED THE IMPLANT WAS NOT BROKEN INTO TWO OR MORE PIECES. THE IMPLANT WAS REMOVED FROM THE PATIENT WITH NO DEBRIS BEING LEFT IN THE PATIENT. THE PATIENT BONE QUALITY WAS NOTED AS POOR. THE SURGEON WAS NOT OFF AXIS DURING THE PROCEDURE. IT IS UNKNOWN IF THE SAME BONE HOLE WAS USED TO THE COMPLETE THE PROCEDURE. THE APPROPRIATE AWL WAS USED DURING THE PROCEDURE. THERE WAS AN AUDIBLE/TACTILE INDICATION OF FAILURE. MINIMAL FORCE WAS USED WHEN THE ANCHOR PULLED OUT. DUAL, ORTHOCORD SUTURES WERE USED. IT IS UNKNOWN WHICH SUTURE LIMBS WERE TESTED TO VERIFY THE REPAIR.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4). THE EXPIRATION DATE IS NOT CURRENTLY AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANCHOR PULLED OUT DURING A ROTATOR CUFF REPAIR OPERATION. THE ANCHOR WAS REPLACED WITH A LARGER ANCHOR (PRODUCT CODE 222305). THERE WERE NO ADVERSE EFFECTS ON THE PATIENT. THERE WAS A 3 MINUTE DELAY TO THE SURGERY. ADDITIONAL INFORMATION WAS OBTAINED ON (B)(6) FROM THE AFFILIATE THAT THE ANCHOR PULLED OUT OF THE BONE WHEN PLACED UNDER TENSION. IT WAS DISCARDED AND IS NOT AVAILABLE FOR COLLECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616000 4.5 HEALIX ADVANCE PEEK ANCHOR WITH ORTHOCORD SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE HWC DEPUY MITEK LLC US L790071 10886705021390

    Patients

    Seq Age Sex Outcome Treatment
    1