BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5 MM / 2.7 MM PLATE REDUCTION INSTRUMENT

    MDR report key: 11995634 · Received June 14, 2021

    Report

    Report Number
    0001822565-2021-01648
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    May 31, 2021
    Report Date
    March 30, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE. UPDATED: B4, B5, D10, G3, G7, H1, H2, H3, H10. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED APPROXIMATELY 1.5 INCHES WAS FRACTURED AND MISSING FROM THE THREADED END. WEAR AND TEAR WAS SEEN WHICH THE INDICATED REPEATED USE DURING A POTENTIAL FIELD AGE OF APPROXIMATELY 4 YEARS. 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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF PHOTOGRAPHS PROVIDED SHOWED THAT THE DEVICE WAS FRACTURED AND HAD SIGNS OF WEAR AND TEAR. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION 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 · 0

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

    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 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 REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DRILLING, THE PLATE REDUCTION INSTRUMENT BROKE. THE BROKEN PART OF THE INSTRUMENT WAS LEFT IN THE BONE. THERE HAS NOT BEEN ANY FURTHER MEDICAL INTERVENTION REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892829 3.5 MM / 2.7 MM PLATE REDUCTION INSTRUMENT TRAUMA, INSTRUMENT HWN ZIMMER BIOMET, INC. 63671934

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Other