BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPACTOR

    MDR report key: 11648355 · Received April 12, 2021

    Report

    Report Number
    0001825034-2021-01020
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    March 17, 2021
    Report Date
    May 6, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWA
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; G3; G6; H1; H2; H6 VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE BROKEN IMPACTOR HEAD. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: ITEM#: 405889, COMP RVS 2.7MM DIA DRL; LOT#: 917190, ITEM#: 405800, COMP. REV SHLDR 9 IN STEINMANN; LOT#: 956560, ITEM#: 110031399, MINI TRAY STD COCR +0 OFFSET; LOT#: 64550787, ITEM#: 110031424, CR VIVACIT-E 36MM BRNG STD; LOT#: 64597874, ITEM#: 113650, COMP PRIMARY STEM 10MM STD; LOT#: 483240, ITEM#: 115310, COMP RVRS SHLDR GLNSP STD 36MM; LOT#: 018180, ITEM#: 180550, COMP LK SCR 3.5HEX 4.75X15 ST; LOT#: 921640, ITEM#: 180551, COMP LK SCR 3.5HEX 4.75X20 ST; LOT#: 214480, ITEM#: 180550, COMP LK SCR 3.5HEX 4.75X15 ST; LOT#: 921700, ITEM#: 180550, COMP LK SCR 3.5HEX 4.75X15 ST; LOT#: 844780, ITEM#: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR; LOT#: 865440, ITEM#: 98-0010-000-18, TRINITY REVERSE SHOULDER; LOT#: UNKKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, LOCATION UNKNOWN. 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 THE ITEM BROKE DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551355 UNKNOWN IMPACTOR INSTRUMENT/EXTREMITY HWA ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1