BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPASS DISPOSABLE NITINOL 10 PK

    MDR report key: 7082027 · Received December 5, 2017

    Report

    Report Number
    0001825034-2017-10774
    Event Type
    Injury
    Date Received
    December 5, 2017
    Date of Event
    November 2, 2017
    Report Date
    January 12, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HXO
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN ¿ EVENTS OCCURRED IN (B)(6). CUSTOMER HAS BEEN INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. HOSPITAL DISCARDED AS BIOHAZARD.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PHOTOS. TWO PICTURES ARE PROVIDED FOR EVALUATION. THE TIP OF THE NITINOL PUSHER SHAFT APPEARS TO BE FRACTURED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE NITINOL PUSHER FRACTURED INSIDE OF THE PATIENT, CAUSING THE SURGEON TO HAVE TO RETRIEVE THE BROKEN PIECE. NO FURTHER PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862240 BIPASS DISPOSABLE NITINOL 10 PK PUSHER, SOCKET HXO ZIMMER BIOMET, INC. N/A 834650

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R