BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM SYSTEM HIGH TORQUE X-LOCK STANDARD BLADE

    MDR report key: 7977680 · Received October 18, 2018

    Report

    Report Number
    0001032347-2018-00689
    Event Type
    Malfunction
    Date Received
    October 18, 2018
    Date of Event
    September 17, 2018
    Report Date
    March 11, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK121589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D11 MEDICAL PRODUCT: BIOMET MICROFIXATION THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW, 1.5X4MM CATALOG #: 91-6704 LOT #: NI THERAPY DATE: SEP 17, 2018 THE FOLLOWING SECTIONS WERE CORRECTED: BRAND NAME CORRECTED FROM 1.5 MM SYSTEM HIGH TORQUE X-LOCK SHORT BLADE TO 1.5MM SYSTEM HIGH TORQUE X-LOCK STANDARD BLADE D4 CATALOG NUMBER CORRECTED FROM 15-1194 TO 15-1196 D4 UNIQUE IDENTIFIER (UDI) NUMBER CORRECTED FROM 00841036032432 TO 00841036032449 MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2018-00749.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE PRODUCT IDENTITY COULD NOT BE CONFIRMED DUE TO THE PART NOT BEING RETURNED. THE 1.5MM SYSTEM HIGH TORQUE X-LOCK STANDARD BLADE (PART# 15-1196, LOT# UNKNOWN) AND THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW, 1.5X4MM (PART# 91-6704, LOT# UNKNOWN) WERE NOT RETURNED AND THEREFORE COULD NOT BE VISUALLY EVALUATED OR FUNCTIONALLY TESTED. BECAUSE THE BLADE COULD NOT BE FUNCTIONALLY TESTED FOR RETENTION WITH A SCREW, THE COMPLAINT CANNOT BE VERIFIED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. THE FOLLOWING FIELDS WERE UPDATED: MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2018-00749-1

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (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.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A COMPLEX FRONTAL CASE A LONG BLADE THAT GOES WITH THE MANUAL DRIVER HANDLE WAS NOT RETAINING THE SCREW DURING A SURGERY. THE SURGEON WAS STILL ABLE TO INSERT THE SCREWS, HE HAD TO HOLD THE SCREW TO THE DRIVER TIP WITH HIS FINGER THE BEST HE COULD. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819570 1.5MM SYSTEM HIGH TORQUE X-LOCK STANDARD BLADE BLADE JEY BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 BIOMET MICROFIXATION SCREWS CATALOG #:NI LOT #:NI| SEE H10 NARRATIVE| BIOMET MICROFIXATION SCREWS CATALOG #:NI LOT #:NI