BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOSORB LS TAPERED PIN KIT

    MDR report key: 6902457 · Received September 28, 2017

    Report

    Report Number
    0001825034-2017-07425
    Event Type
    Malfunction
    Date Received
    September 28, 2017
    Date of Event
    September 5, 2017
    Report Date
    June 15, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    OVZ
    PMA / PMN Number
    PK140625
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. VISUAL INSPECTION OF THE RETURNED PRODUCT DETERMINED THAT THE PRODUCT WAS OPENED AND EVIDENCE OF A COMPLETE SEAL IS PRESENT AROUND THE ENTIRE CAVITY FLANGE. TWO K-WIRES CAN BE SEEN IN THE BLISTER TRAY HOWEVER AN ORTHOSORB PIN IS NOT PRESENT. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KNEE SURGERY, THE IMPLANT WAS FOUND MISSING FROM PACKAGE. HOWEVER, THE PRODUCT HAD THE CORRECT K-WIRE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680404 ORTHOSORB LS TAPERED PIN KIT PIN, FIXATION, RESORBABLE, HARD TISSUE OVZ ZIMMER BIOMET, INC. N/A 547840

    Patients

    Seq Age Sex Outcome Treatment
    1