BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMS SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/PK 2.0MM X 5MM

    MDR report key: 10253165 · Received July 9, 2020

    Report

    Report Number
    0001032347-2020-00296
    Event Type
    Injury
    Date Received
    July 9, 2020
    Date of Event
    June 12, 2020
    Report Date
    October 30, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    UDI-DI
    00841036089528
    PMA / PMN Number
    K121589
    Removal / Correction Number
    N/A
    Adverse Event
    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 DISTRIBUTOR PROVIDED INVALID LOT NUMBERS FOR SOME OF THE CONCOMITANT MEDICAL PRODUCTS; THESE ITEMS HAVE BEEN RE-SUBMITTED AS UNKNOWN LOT NUMBERS WHILE AWAITING CUSTOMER RESPONSE. D11 ¿ CONCOMITANT MEDICAL PRODUCTS: 2.0MM SYSTEM PLATE DOUBLE-Y-SHAPE, LONG, PART# 01-9262, LOT# 333920. 2.0MM SYSTEM PLATE 4 HOLE PLATE, STRAIGHT, MEDIUM, PART# 01-9288, LOT# 706750. TMS SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/PK, PART# 25-2005, LOT# 426950. TMS SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/PK, PART# 25-2005, LOT# NI. TMS SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/PK, PART# 25-2005, LOT# 493230. TMS SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/PK, PART# 25-2005, LOT# NI. TMS SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/PK, PART# 25-2007, LOT# NI.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS CONSIDERED TO BE CONFIRMED BECAUSE IT WAS REPORTED THAT POST-OPERATIVE INTERVENTION WAS REQUIRED TO PRECLUDE SERIOUS INJURY TO THE PATIENT. THESE PLATES AND SCREWS WERE NOT RETURNED FOR INVESTIGATION AND NO PHOTOS, SCANS, X-RAYS, OR PHYSICIAN'S REPORTS WERE PROVIDED. FOR THESE REASONS, NO FUNCTIONAL TESTING OR VISUAL EVALUATIONS COULD BE CONDUCTED. THE DHR WAS REVIEWED AND NO NON-CONFORMANCES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS THE ONLY COMPLAINT FOR THIS ITEM# 25-2005, LOT# 426950. THE MOST LIKELY UNDERLYING CAUSE OF THE INFECTION COULD NOT BE DETERMINED. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2020-00294, 0001032347-2020-00295, 0001032347-2020-00297, 0001032347-2020-00298, 0001032347-2020-00299, 0001032347-2020-00300. MEDICAL PRODUCTS: 2.0MM SYSTEM PLATE DOUBLE-Y-SHAPE, LONG, PART# 01-9262, LOT# 333920. 2.0MM SYSTEM PLATE 4 HOLE PLATE, STRAIGHT, MEDIUM, PART# 01-9288, LOT# 706750. TMS SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/PK, PART# 25-2005, LOT# 426950. TMS SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/PK, PART# 25-2005, LOT# 636840B. TMS SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/PK, PART# 25-2005, LOT# 493230. TMS SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/PK, PART# 25-2005, LOT# 653390B. TMS SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/PK, PART# 25-2007, LOT# 651770T. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. FOREIGN REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A SUSPECTED INFECTION FOUR (4) WEEKS FOLLOWING IMPLANTATION OF CMF DEVICES AND UNDERWENT A REVISION FIVE (5) WEEKS FOLLOWING IMPLANTATION OF CMF DEVICES. DURING THE RE-OPERATION, THE SURGEON NOTED THE INFECTION WAS A TISSUE PROBLEM AND NOT AN EFFECT OF THE PLATE. THE PATIENT¿S TISSUES WERE WASHED AND THE DEVICES REMAIN IMPLANTED. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717989 TMS SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/PK 2.0MM X 5MM PLATE, BONE JEY BIOMET MICROFIXATION N/A 426950 00841036089528

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R