BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5 MM CANNULATED LOCKING SCREW 90 MM LENGTH

    MDR report key: 13891440 · Received March 24, 2022

    Report

    Report Number
    0001822565-2022-00838
    Event Type
    Injury
    Date Received
    March 24, 2022
    Date of Event
    February 21, 2022
    Report Date
    July 11, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    UDI-DI
    00889024059542
    PMA / PMN Number
    K042598
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-00840 (SCREW) AND 0001822565-2022-00658 (PLATE).

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-00840-1. D10: MEDICAL PRODUCTS: ITEM#: 00235700310, 3.5 MM PROXIMAL LATERAL TIBIAL PLATE RIGHT 10 HOLES 152 MM LENGTH; LOT#: 64298407; ITEM#: 00235908536, 3.5 MM CANNULATED LOCKING SCREW 85 MM LENGTH; LOT#: 62120799; ITEM#: 00235908536, 3.5 MM CANNULATED LOCKING SCREW 85 MM LENGTH; LOT#: 60705515; ITEM#: 00235908536, 3.5 MM CANNULATED LOCKING SCREW 85 MM LENGTH; LOT#: 60705515; ITEM#: 00235903835, 3.5 MM LOCKING SCREW 38 MM LENGTH; LOT#: 63748422; ITEM#: 00235908036, 3.5 MM CANNULATED LOCKING SCREW 80 MM LENGTH; LOT#: 62121947. THE CONICAL THREAD FORM OF THE ZPLP 3.5MM CANNULATED LOCKING SCREWS EXHIBIT DAMAGE WHICH CAUSED THEM TO FAIL OVERLAY 25-2001-560-06-L. THE THREAD FORM OF THE SHAFT IS CONFORMING TO OVERLAY 25-2001-560-06-L EXCEPT WHERE DAMAGE IS SEEN NEAR THE CONICAL HEAD. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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

    IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO LOCKING SCREWS IN PROXIMAL TIBIA PLATE BACKING OUT AND NOT LOCKED IN PROPERLY. THE ISSUE HAD OCCURRED DUE TO THE PATIENT FALLING AND THE TWO LONGEST SCREWS HAD BACKED OUT AS A RESULT. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337703 3.5 MM CANNULATED LOCKING SCREW 90 MM LENGTH PLATE, FIXATION HWC ZIMMER BIOMET, INC. NI 62098620 00889024059542

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H