BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEADLESS TROCAR DRILL PIN 3.2 MM DIAMETER 75 MM LENGTH

    MDR report key: 8264795 · Received January 21, 2019

    Report

    Report Number
    0001822565-2019-00278
    Event Type
    Malfunction
    Date Received
    January 21, 2019
    Date of Event
    December 24, 2018
    Report Date
    July 18, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI# (01) 00889024201620. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. A VISUAL EVALUATION OF THE FOUR RETURNED PRODUCTS CONFIRMED THAT THE END OF THE CAVITY 88-4400-404-00 EXHIBITS STRESS MARKS, THE PEEL END OF THE TYVEK 88-4400-406-00 HAS BEEN PEELED BACK AND SHOWS ADHESIVE TRANSFER COVERING THE WHOLE FLANGE. ONE SEALED CAVITY AND PRODUCT WAS NOT RETURNED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE LIKELY CONDITION OF THE PART WHEN IT LEFT ZIMMER BIOMET CONTROL IS CONSIDERED CONFORMING BASED ON THE EVALUATION OF THE RETURNED PRODUCT AND THE DHR REVIEW. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN: (B)(6). CUSTOMER HAS NOT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PRIMARY TOTAL KNEE ARTHROPLASTY, THE TYVEK ON A DRILL PIN PEELED AWAY CAUSING A STERILITY ISSUE. ANOTHER DRILL PIN WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57063 HEADLESS TROCAR DRILL PIN 3.2 MM DIAMETER 75 MM LENGTH DRILL PIN LXH ZIMMER BIOMET, INC. N/A 64131885

    Patients

    Seq Age Sex Outcome Treatment
    1