BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90° CONTRA ANGLE DRIVER

    MDR report key: 7557890 · Received May 31, 2018

    Report

    Report Number
    0001032347-2018-00321
    Event Type
    Malfunction
    Date Received
    May 31, 2018
    Date of Event
    May 4, 2018
    Report Date
    October 26, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK142823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE 90 DEGREE CONTRA ANGLE SCREWDRIVER (PART# 24-1189, LOT# 191750) AND CONTRA ANGLE TEMPORARY FIXATION SCREW (PART# 76-0017, LOT# UNKNOWN) WERE RETURNED IN A BIOHAZARDOUS CONDITION. VISUAL INSPECTION OF THE DEVICE THROUGH THE BAG SHOWS THERE IS A TEMPORARY FIXATION SCREW STILL STUCK IN THE DRIVER'S COLLET. THE DEVICE WAS REMOVED FROM THE BIOHAZARD BAG AND DISCOLORATION WAS OBSERVED. FUNCTIONAL TESTING CONFIRMS THAT THE PIN CAN NOT BE REMOVED. DEVICE HISTORY RECORD (DHR) OF THE SCREWDRIVER WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED FOR THE TEMPORARY FIXATION SCREW AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO THE MANUFACTURER'S INSPECTION METHODS. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2018-00322-1.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED TO DOCUMENT THE RESULTS OF THE DEVICE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: BIOMET MICROFIXATION RIBFIX BLU TEMPORARY FIXATION SCREW CATALOG #: 76-0017 LOT #: NI. THERAPY DATE: (B)(6) 2018. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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 REPORT: 0001032347-2018-00322.

    Description of Event or Problem · 1

    IT WAS REPORTED A PIN BECAME LOCKED IN THE DRIVER. THE ISSUE WAS IDENTIFIED AFTER THE CASE WHEN THE HOSPITAL STAFF WAS BREAKING DOWN THE EQUIPMENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401078 90° CONTRA ANGLE DRIVER SCREWDRIVER HRS BIOMET MICROFIXATION N/A 191750

    Patients

    Seq Age Sex Outcome Treatment
    1