BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SCREW

    MDR report key: 18171582 · Received November 20, 2023

    Report

    Report Number
    0001825034-2023-02706
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    October 25, 2023
    Report Date
    March 6, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MDM
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL PRODUCT: CATALOG #: 418078, EXPLOR OFFSET HANDLE, LOT # 906140. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. H3 OTHER TEXT : NOT RETURNED.

    Additional Manufacturer Narrative · 0

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATES THE FRACTURED SCREW IS FROM THE INSTRUMENT HANDLE. THIS MALFUNCTION DID NOT CAUSE OR CONTRIBUTED TO A SERIOUS INJURY. THEREFORE, THIS IS NOT REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PRIMARY SURGERY, A SCREW FRACTURED AND THE HANDLE WAS NOT STABLE. DEFAULT INSTRUMENTS WERE USED TO COMPLETED THE SURGERY. NO PATIENT HARM OR IMPACT OCCURRED. NO FURTHER INFORMATION IS KNOWN AT THIS TIME.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATES THE FRACTURED SCREW IS FROM THE INSTRUMENT HANDLE. THIS MALFUNCTION DID NOT CAUSE OR CONTRIBUTED TO A SERIOUS INJURY. THEREFORE, THIS IS NOT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2165679 UNKNOWN SCREW EXTREMITIES IMPLANT MDM ZIMMER BIOMET, INC. N/A N/A
    334183 UNKNOWN SCREW EXTREMITIES IMPLANT MDM ZIMMER BIOMET, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H10