BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0X7MM LACTOSORB SCREW

    MDR report key: 19312194 · Received May 14, 2024

    Report

    Report Number
    0001032347-2024-00158
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    April 4, 2024
    Report Date
    September 6, 2024
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    UDI-DI
    00841036055028
    PMA / PMN Number
    K971870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). D10: MEDICAL PRODUCT - ZIMMER BIOMET 2.0X7MM LACTOSORB SCREW CATALOG #: 915-2301 LOT #: 66053354; ZIMMER BIOMET 2.0X7MM LACTOSORB SCREW CATALOG #: 915-2301 LOT #: 66169236 ZIMMER BIOMET 2.0X7MM LACTOSORB SCREW CATALOG #: 915-2301-EA LOT #: 66253376; ZIMMER BIOMET 2.0X7MM LACTOSORB SCREW CATALOG #: 915-2301-EA LOT #: 66321061; ZIMMER BIOMET 1.5MM ADJUSTABLE SELF-DRILLING TAP #: 915-1595 LOT #: 557203; ZIMMER BIOMET LACTOSORB SYSTEM L-PLATE LEFT REGULAR CATALOG #: 915-2102 LOT #: 511700; ZIMMER BIOMET LACTOSORB SYSTEM L-PLATE RIGHT REGULAR CATALOG #: 915-2101 LOT #: 139240; ZIMMER BIOMET BATTERY POWERED POWERDRIVER CATALOG #: 50-1000 LOT #: UNKNOWN. G2: FOREIGN - JAPAN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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 DURING SURGERY, THE HEX HEAD OF THE SCREWS DID NOT BREAK PROPERLY AND THE SCREWS CONTINUED TO SPIN IN THE BONE. THERE WAS A DELAY OF 40 MINUTES AS THE SCREWS WERE REMOVED AND THE SURGERY WAS COMPLETED WITH OTHER PRODUCT. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    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
    474845 2.0X7MM LACTOSORB SCREW SCREW HWC BIOMET MICROFIXATION N/A 66053354 00841036055028

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown