BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5 HEALIXADVPEEK3SUTANC PCORD

    MDR report key: 7544354 · Received May 25, 2018

    Report

    Report Number
    1221934-2018-50853
    Event Type
    Malfunction
    Date Received
    May 25, 2018
    Date of Event
    April 24, 2018
    Report Date
    April 30, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705024759
    PMA / PMN Number
    K133794
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. THE EXPIRATION DATE WAS REPORTED AS UNKNOWN IN THE INITIAL REPORT AND HAS BEEN UPDATED AS 5/31/2020; THEREFORE, UDI: (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS DISCARDED BY THE CUSTOMER, HOWEVER PHOTOS OF THE ACTUAL DEVICE WERE RECEIVED AND EXAMINED. THIS COMPLAINT WAS CONFIRMED.   A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PRODUCT CODE 223135-LOT #L436568 COMBINATION AND NO NON-CONFORMANCES WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT WAS BROUGHT BACK FOR A REVISION ROTATOR CUFF REPAIR. WHEN EXAMINING THE RETEAR, WE NOTICED THAT THE FIRST ANCHOR HAD PULLED OUT AND CRACKED ALONG THE SIDE OF THE ANCHOR. PATIENT CONSEQUENCE? UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387778 4.5 HEALIXADVPEEK3SUTANC PCORD SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE MAI DEPUY MITEK LLC US L436568 10886705024759

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR