BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRO LINK ANCHOR 4.5MM SP

    MDR report key: 7465281 · Received April 26, 2018

    Report

    Report Number
    3006108336-2018-00005
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Date of Event
    March 15, 2018
    Report Date
    September 17, 2018
    Manufacturer
    CAYENNE MEDICAL
    Product Code
    MBI
    PMA / PMN Number
    PK122314
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE LOT # 63752-3, UDI (B)(4). DEVICE LOT# 63367-2, UDI: (B)(4). EVALUATION NOTES: BOTH DEVICES WERE RETURNED FOR EVALUATION. BOTH DEVICES WITH THE PACKAGING WERE RETURNED. DEVICE 1: 63367-2. THE INSERTER TIP WAS BENT AND THE IMPLANT BROKEN IN HALF. THE INSERTER HAD NOT BEEN DEPLOYED. DEVICE 2: 63752-3. THE INSERTER TIP WAS BENT AT A SEVERE ANGLE WITH THE IMPLANT STILL ON THE INSERTER. THE IMPLANT WAS BENT, BUT DID NOT BREAK. BASED ON THE DESCRIPTION OF THE COMPLAINT AND EVALUATION OF THE DEVICES IT CAN BE DETERMINED THAT THE IMPLANTS BENT OR BROKE MOST LIKELY AS A RESULT OF HARD BONE AND NO DRILL WAS USED PER THE IFU (70932). THE IFU STATES ¿WHEN IMPLANTING INTO HARD BONE, UTILIZE THE CM-9138 QUATTRO DRILL.¿

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2018 TO CAYENNE MEDICAL THAT AN EVENT INVOLVING CAYENNE MEDICAL PRODUCTS WAS REPORTED TO ZIMMERBIOMET FRANCE BY ANSM (FRENCH COMPETENT AUTHORITY). IT WAS REPORTED THAT "A QUATTRO LINK ANCHOR BROKE DURING IMPLANTATION AND A PIECE OF ANCHOR REMAINED IN THE SHOULDER OF THE PATIENT. THE SECOND ANCHOR TWISTED."

    Additional Manufacturer Narrative · 1

    TWO LOT NUMBERS WERE INVOLVED: P/N CM-9145SP, L/N 63367-2, EXPIRATION 07/21/2022 , 5 YEAR SHELD LIFE; L/N 63752-3, EXPIRATION 08/28/2022, 5 YEAR SHELF LIFE.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2018 TO CAYENNE MEDICAL THAT AN EVENT INVOLVING CAYENNE MEDICAL PRODUCTS WAS REPORTED TO ZIMMER BIOMET (B)(4) BY (B)(6). IT WAS REPORTED THAT " A QUATTRO LINK ANCHOR BROKE DURING IMPLANTATION AND A PIECE OF ANCHOR REMAINED IN THE SHOULDER OF THE PATIENT. THE SECOND ANCHOR TWISTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306708 QUATTRO LINK ANCHOR 4.5MM SP KNOTLESS SUTURE ANCHOR MBI CAYENNE MEDICAL N/A 63367-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CM-9145SP LOT# : 63752-3.