BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW 2.4X12MM

    MDR report key: 16898799 · Received May 9, 2023

    Report

    Report Number
    0001032347-2023-00167
    Event Type
    Injury
    Date Received
    May 9, 2023
    Date of Event
    April 12, 2023
    Report Date
    August 23, 2023
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    K110574
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED FOR THESE DEVICES. 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.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT CMP-0873115 D10: MEDICAL PRODUCT - ZIMMER BIOMET STERNALOCK BLU 8 HOLE X PLATE CATALOG# 73-2623 LOT# UNKNOWN QUANTITY 2; ZIMMER BIOMET STERNALOCK BLU 12MM SCREW CATALOG# 73-2412 LOT# UNKNOWN QUANTITY 12;ZIMMER BIOMET STERNALOCK BLU 14MM SCREW CATALOG# 73-2414 LOT# UNKNOWN QUANTITY 4; UNKNOWN STERNAL WIRE CATALOG# UNKNOWN LOT # UNKNOWN G2: FOREIGN - UK CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. 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: 0001032347-2023-00164, 0001032347-2023-00165, 0001032347-2023-00166, 0001032347-2023-00168, 0001032347-2023-00169, 0001032347-2023-00170, 0001032347-2023-00171, 0001032347-2023-00172, 0001032347-2023-00173, 0001032347-2023-00174, 0001032347-2023-00175, 0001032347-2023-00176, 0001032347-2023-00177, 0001032347-2023-00178, 0001032347-2023-00179, 0001032347-2023-00180, 0001032347-2023-00181

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A MIDLINE STERNOTOMY APPROXIMATELY THREE MONTHS AGO DURING WHICH STERNALOCK BLU PRODUCT WAS USED TO CLOSE THE STERNUM. THE PATIENT IS NOW EXPERIENCING STERNAL SEPARATION AND THE PRODUCT IS NO LONGER KEEPING THE STERNUM TOGETHER. THE PATIENT HAS DIABETES AND HIGH BMI AND IS CURRENTLY BEING TREATED FOR STERNAL SEPARATION AND IS UNDERGOING VAC TREATMENT, THEREAFTER, THE PLATES AND SCREWS WILL BE REMOVED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883302 SCREW 2.4X12MM SCREW HRS BIOMET MICROFIXATION N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other