BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACTOSORB SYSTEM LACTOSORB DIRECT DRIVER BLADE

    MDR report key: 10529187 · Received September 14, 2020

    Report

    Report Number
    0001032347-2020-00435
    Event Type
    Malfunction
    Date Received
    September 14, 2020
    Date of Event
    August 26, 2020
    Report Date
    March 18, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HXX
    UDI-DI
    00841036055714
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; G3; G6; H1; H2; H3; H6. A VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED BLADES. THE BLADES SHOWED SIGNS OF GENERAL USE BUT NO VISIBLE DAMAGE WAS PRESENT. ALL THREE ORIENTATIONS WERE CHECKED AND THE FITS MET ALL SPECIFICATIONS. THE BLADES ARE FUNCTIONING AS THEY SHOULD. MEDICAL RECORDS WERE NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED AS THE RETURNED ITEMS FUNCTIONED AS INTENDED. NO PROBLEM WAS FOUND WITH PRODUCT. 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MULTIPLE BLADES WERE UNABLE TO RETAIN SCREWS DURING AN UPPER AND LOWER OSTEOTOMY. THE FIVE (5) MM SCREWS COULD BE GRASPED AND THE SEVEN (7) MM SCREWS COULD NOT BE GRASPED. THE PROCEDURE WAS COMPLETED WITH ALTERNATE BLADES. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001032347-2020-00433, 0001032347-2020-00434. LOT NUMBER: BASED ON A REVIEW OF INVENTORY TRANSACTIONS AND THE CUSTOMER'S PURCHASE HISTORY, THERE ARE TWO (2) POSSIBLE LOTS: 061150, 394730. MEDICAL PRODUCTS: LACTOSORB SYSTEM LACTOSORB DIRECT DRIVER BLADE, PART# 915-2451, SERIAL# 392193, POSSIBLE LOT# 745970, 329600, 195230; LACTOSORB SYSTEM LACTOSORB DIRECT DRIVER BLADE, PART# 915-2451, LOT# 572419; LACTOSORB SYSTEM LACTOSORB DIRECT DRIVER BLADE, PART# 915-2451, SERIAL# 475276, POSSIBLE LOT# 061150, 394730; 2.0 LACTOSORB SYSTEM 2.0 X 5 MM DIRECT DRIVE SCREW, PART# 915-2200, LOT# N; 2.0 LACTOSORB SYSTEM 2.0 X 7 MM DIRECT DRIVE SCREW, PART# 915-2201, LOT# NI. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT SOURCE ¿ (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE BLADES WERE UNABLE TO RETAIN SCREWS DURING A SURGICAL PROCEDURE. THE FIVE (5) MM SCREWS COULD BE GRASPED AND THE SEVEN (7) MM SCREWS COULD NOT BE GRASPED. THE PROCEDURE WAS COMPLETED WITH ALTERNATE BLADES. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991867 LACTOSORB SYSTEM LACTOSORB DIRECT DRIVER BLADE SCREWDRIVER HXX BIOMET MICROFIXATION N/A SEE H10 NARRATIVE 00841036055714

    Patients

    Seq Age Sex Outcome Treatment
    1