BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90° CONTRA ANGLE DRIVER

    MDR report key: 7804424 · Received August 22, 2018

    Report

    Report Number
    0001032347-2018-00556
    Event Type
    Malfunction
    Date Received
    August 22, 2018
    Date of Event
    July 23, 2018
    Report Date
    January 10, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK142823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. THE 90 DEGREE CONTRA ANGLE SCREWDRIVER (PART# 24-1189, LOT# 999220 (QTY 1), LOT# 893200 (QTY 2), LOT# 727920 (QTY 1)) AND THE CONTRA ANGLE TEMPORARY FIXATION SCREW (PART# 76-0017, LOT# 632390 (QTY 2)) WERE VISUALLY EVALUATED. THE DRIVERS WERE RETURNED WITH THE SCREWS REMOVED. THE DRIVERS HAD MINOR SCRATCHING AND DISCOLORATION AS SIGNS OF GENERAL USE. THE SCREWS HAD SOME DAMAGE ALONG THE THREADS THAT WAS CONSISTENT WITH THE CLAIM THAT THEY WERE REMOVED FROM THE DRIVERS USING A PAIR OF NEEDLE NOSE PLIERS. THE SCREWS WERE INSERTED INTO EACH DRIVER AND EASILY REMOVED. AN ATTEMPT WAS MADE TO INSERT THE SCREWS INTO A BLOCK OF WHITE OAK WOOD TO SEE IF THE INSERTION RESISTANCE WOULD CAUSE THE SCREWS TO BECOME STUCK IN THE DRIVER, HOWEVER, THE SCREWS WERE STILL EASY TO REMOVE. SINCE THE REPORTED EVENT COULD NOT BE RECREATED, THE COMPLAINT CANNOT BE VERIFIED. DEVICE HISTORY RECORDS (DHR'S) WERE REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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. THE FOLLOWING SECTIONS WERE UPDATED: ETHNICITY, DATE OF THIS REPORT, DATE RECEIVED BY MANUFACTURER, TYPE OF REPORT AND FOLLOW-UP NUMBER, FOLLOW-UP TYPE, DEVICE EVALUATED BY MANUFACTURER , METHOD CODE , RESULTS CODE, CONCLUSIONS CODE AND ADDITIONAL NARRATIVES/DATA. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2018-00557-1, 0001032347-2018-00563-1, AND 0001032347-2018-00564-1.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICE: BIOMET MICROFIXATION RIBFIX BLU SYSTEM TEMPORARY FIXATION SCREW, CONTRA ANGLE CATALOG #: 76-0017, LOT #: 632390. THERAPY DATE: (B)(6) 2018. THE CUSTOMER REPORTED THREE CONTRA-ANGLE DRIVERS; HOWEVER FOUR CONTRA-ANGLE DRIVERS WERE RETURNED. THE CUSTOMER DOES NOT KNOW WHICH LOTS WERE USED IN THE PROCEDURE; THEREFORE ALL LOTS ARE BEING REPORTED. 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 REPORTS: 0001032347-2018-00557, 0001032347-2018-00563, AND 0001032347-2018-00564.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TEMPORARY FIXATION SCREW WOULD NOT DISENGAGE FROM THE 90 DEGREE SCREWDRIVER DURING A RIB FIXATION CASE. THE SURGEON USED THE 90 DEGREE SCREWDRIVER (24-1189) AND IT WORKED WELL FOR THE MOST PART BUT NOT AS WELL WHEN HE USED IT IN CONJUNCTION WITH THE 90 DEGREE TEMPORARY FIXATION SCREW (76-0017). THE TEMPORARY SCREW WOULD NOT DISENGAGE EASILY FROM THE SCREWDRIVER WHEN USED. THE SURGEON WAS ABLE TO USE IT TO A DEGREE, BY LEAVING THE SCREWDRIVER AND SCREW ENGAGED THROUGH THE PLATE INTO THE BONE, BUT THIS WAS NOT PREFERRED. THE SURGEON HAD THIS PROBLEM WITH TWO OF THE DRIVERS AND WITH TWO DIFFERENT TEMPORARY FIXATION SCREWS. THERE WAS A LOT OF TROUBLE DISLODGING THE TEMPORARY FIXATION SCREW FROM THE DRIVER AFTER USE WITH THE SCRUB TECH. EVENTUALLY THE SCRUB TECH DID USE A PAIR OF NEEDLE DRIVERS TO PULL OUT THE TEMPORARY FIXATION SCREW FROM THE DRIVER. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646856 90° CONTRA ANGLE DRIVER SCREWDRIVER HRS BIOMET MICROFIXATION N/A 999220

    Patients

    Seq Age Sex Outcome Treatment
    1