BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90° CONTRA ANGLE DRIVER

    MDR report key: 7656495 · Received July 2, 2018

    Report

    Report Number
    0001032347-2018-00422
    Event Type
    Malfunction
    Date Received
    July 2, 2018
    Date of Event
    June 5, 2018
    Report Date
    December 13, 2018
    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

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE 90 DEGREE CONTRA ANGLE SCREWDRIVER (PART# 24-1189, LOT# 056380 (QTY 1), LOT# 056370 (QTY 1)) AND THE CONTRA ANGLE TEMPORARY FIXATION SCREW (PART# 76-0017, LOT# 828490 (QTY 2)) WERE VISUALLY EVALUATED. THE BODIES AND HEADS OF THE SCREWDRIVERS WERE DISCOLORED. THE TEMPORARY FIXATION SCREWS APPEARED TO BE IN GOOD CONDITION, BUT THE INTERFACES BETWEEN THE SCREWS AND THE SCREWDRIVERS WERE ALSO DISCOLORED. THE SCREWDRIVERS WERE FUNCTIONALLY TESTED BY ROTATING THE KNOB IN BOTH CLOCKWISE AND COUNTERCLOCKWISE DIRECTIONS. THE SCREWDRIVER FROM LOT# 056370 HAD MINIMAL STICKING DURING ROTATION AND WAS SQUEAKING. THE SCREWDRIVER FROM LOT# 056380 WAS COMPLETELY SEIZED AND COULD NOT BE ROTATED. NEITHER SCREWDRIVER WOULD RELEASE THE TEMPORARY SCREW FROM THE COLLET. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO THE SUPPLIER USING BLADES, AND NOT THE MIN/MAX GAGE, TO DESIGN THE COLLET RESULTING IN THE COLLET FAILING THE MAX GAGE INSPECTION. 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 REPORTS: 0001032347-2018-00423-1 AND 0001032347-2018-00424-1.

    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). MEDICAL PRODUCT: BIOMET MICROFIXATION RIBFIX BLU SYSTEM TEMPORARY FIXATION SCREW, CONTRA ANGLE CATALOG #: 76-0017 LOT #: 828490. 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 REPORTS: 0001032347-2018-00423 AND 0001032347-2018-00424.

    Description of Event or Problem · 1

    IT WAS REPORTED TWO (2) 90 DEGREE SCREWDRIVERS HAVE SHORT TEMPORARY FIXATION SCREWS STUCK INSIDE. THE PATIENT WAS NOT INJURED AND THERE WAS NO DELAY IN THE CASE. THE PROCEDURE WAS COMPLETED USING BACKUP 90 DEGREE SCREWDRIVERS. THE CASE ENDED WELL. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497631 90° CONTRA ANGLE DRIVER SCREWDRIVER HRS BIOMET MICROFIXATION N/A 056380

    Patients

    Seq Age Sex Outcome Treatment
    1