BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACTOSORB SYSTEM 14MM RAPID FLAP

    MDR report key: 9872164 · Received March 24, 2020

    Report

    Report Number
    0001032347-2020-00185
    Event Type
    Malfunction
    Date Received
    March 24, 2020
    Date of Event
    March 11, 2020
    Report Date
    July 31, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    UDI-DI
    00841036053864
    PMA / PMN Number
    K003281
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS NON-VERIFIABLE. THE LACTO 14MM RAPIDFLAP CLAMP (ITEM# 915-0020, LOT# 615760, QTY 3) WERE NOT RETURNED FOR INVESTIGATION AND NO PHOTOS WERE PROVIDED. FOR THESE REASONS, NO VISUAL INSPECTIONS OR FUNCTIONAL TESTING COULD BE CONDUCTED. THE DHR FOR THESE PRODUCTS WAS REVIEWED, NO NON-CONFORMANCES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS THE ONLY COMPLAINT FOR THIS ITEM# 915-0020, LOT# 615760. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: BAXTER FIBRIN SEALANT PATCH, PART# NI, LOT# NI; JOHNSON AND JOHNSON EVICAL FIBRIN SEALANT, PART# NI, LOT# NI; UNKNOWN PDS SUTURES, PART# NI, 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 THE BIO-ABSORBABLE CRANIAL FIXATION CLAMPS FRACTURED INTRA-OPERATIVELY DURING A INFRATENTORIAL CRANIOTOMY. ANOTHER PACK OF BONE CLAMPS WAS OPENED BUT WERE FOUND IN AN UNUSABLE CONDITION. THE FASCIA SUTURES, FIBRIN PATCH AND FIBRIN SEALANT THAT WERE ALREADY IN PLACE WERE REMOVED TO FACILITATE REMOVAL OF THE FRACTURED CRANIAL FIXATION CLAMPS, RESULTING IN A 20 MINUTE DELAY. THE PATIENT WAS CLOSED WITH PDS SUTURES. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338096 LACTOSORB SYSTEM 14MM RAPID FLAP PLATE, BONE JEY BIOMET MICROFIXATION N/A 615760 00841036053864

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Hospitalization| R