BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSS LOCKING PIN

    MDR report key: 7203966 · Received January 18, 2018

    Report

    Report Number
    0001825034-2018-00324
    Event Type
    Malfunction
    Date Received
    January 18, 2018
    Date of Event
    December 21, 2017
    Report Date
    October 24, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). IT IS INDICATED THAT PRODUCT WILL BE RETURNED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 32-472106, OSS LOCK PIN INSERTER, LOT # 141930. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. ONLY THE LOCKING PIN WAS RETURNED FOR EVALUATION. DIMENSIONAL ANALYSIS SHOWED THE LOCKING PIN CONFORMING TO SPECIFICATION. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 KNEE PROCEDURE THAT THE LOCKING PIN COULD NOT BE DISENGAGED FROM THE LOCKING INSERTER AFTER THE PIN WAS INSERTED. SUBSEQUENTLY, THE LOCKING PIN WAS PULLED BY PLIERS AND ANOTHER LOCK PIN WAS USED TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

    NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47465 OSS LOCKING PIN PROSTHESIS KNEE JDI ZIMMER BIOMET, INC. N/A 104770

    Patients

    Seq Age Sex Outcome Treatment
    1