BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANATOMICAL SHOULDER, REVERSE, DRILL FOR GLENOID

    MDR report key: 8694484 · Received June 13, 2019

    Report

    Report Number
    0009613350-2019-00383
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Date of Event
    May 3, 2019
    Report Date
    February 21, 2020
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWS
    UDI-DI
    00889024287464
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY INVESTIGATION RESULT. VISUAL EXAMINATION: IT CAN BE CONFIRMED THAT THE TWO PINS AT THE CONNECTION SHAFT OF THE INSTRUMENT HAVE FRACTURED OFF. THE PRODUCT IS INTENDED FOR TREATMENT. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    PLEASE REFER TO REPORT 0009613350-2019-00383.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE X-RAYS BUT RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE, AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THA DURING SURGERY THE SUPPORTING PINS OF DRILL WERE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491484 ANATOMICAL SHOULDER, REVERSE, DRILL FOR GLENOID N/A KWS ZIMMER GMBH N/A 14.045377 00889024287464

    Patients

    Seq Age Sex Outcome Treatment
    1