BEUDAMED
    FDA Adverse Event Injury Summary report: N

    90° CONTRA ANGLE DRIVER

    MDR report key: 7827889 · Received August 29, 2018

    Report

    Report Number
    0001032347-2018-00581
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    August 1, 2018
    Report Date
    January 30, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK142823
    Adverse Event
    Yes
    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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2018-00582-1.

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE THREE (3) 90 DEGREE CONTRA ANGLE SCREWDRIVER (PART# 24-1189, LOT# 267770) AND CONTRA ANGLE TEMPORARY FIXATION SCREWS (PART# 76-0017, LOT# 267530, 106440, 703610) WERE VISUALLY EVALUATED. THE DRIVERS SHOWED SIGNS OF USE WITH SOME MINOR DISCOLORATION. ONE OF THE TEMPORARY SCREWS WAS SEVERELY BENT IN THE COLLET, ANOTHER WAS SLIGHTLY BENT, AND ONE APPEARED TO BE IN GOOD CONDITION. ALL THREE ASSEMBLIES WERE FUNCTIONALLY TESTED BY ATTEMPTING TO REMOVE THE SCREW FROM THE COLLET OF THE DRIVERS. NONE OF THE TEMPORARY SCREWS COULD BE REMOVED FROM THE COLLET. THE DRIVERS WERE DISASSEMBLED FOR FURTHER INSPECTION. WHEN THE COVERS OF THE HEAD ASSEMBLIES WERE REMOVED, ALL THREE SCREWS APPEARED TO BE ROTATED INSIDE THE DRIVER COLLETS AND COULD NOT BE REMOVED WITHOUT BEING ROTATED FIRST PRIOR TO PULLING THEM OUT. WEAR WAS OBSERVED ON THE MATING SURFACES OF THE SCREWS AND INSIDE THE DRIVER COLLETS. DEVICE HISTORY RECORDS (DHRS) WERE REVIEWED AND NO DISCREPANCIES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO EXCESSIVE TORQUE WAS APPLIED, BEYOND WHAT IS REQUIRED TO SEAT THE SCREW. THE EXCESSIVE TORQUE WORE DOWN THE SCREW AND COLLET, THEN CAUSED THE COLLET TO ROTATE AROUND THE SCREW. THE INSTRUCTIONS FOR USE (IFU) FOR THESE PRODUCTS STATES IN THE SECTION TITLED 'WARNINGS AND PRECAUTIONS': AVOID UNDUE STRESS OR STRAIN WHEN HANDLING OR CLEANING INSTRUMENTS. 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: 0001032347-2018-00582-2, 0001032347-2019-00064, AND 0001032347-2019-00065.

    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 #: NI; BIOMET MICROFIXATION RIBFIX BLU SYSTEM SCREW, EMERGENCY CANCELLOUS X-DRIVE LOCKING 2.7 X 12 MM, CATALOG #: 76-2712, LOT #: NI. THERAPY DATE: (B)(6) 2018. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2018-00582.

    Description of Event or Problem · 1

    IT WAS REPORTED THREE TEMPORARY FIXATION SCREWS BECAME STUCK IN THREE CONTRA ANGLE DRIVERS. THE SURGEONS WERE WORKING ON A VERY FAR POSTERIOR FRACTURE ON RIB #3. THE SURGEONS WERE ABLE TO RETRIEVE THE SCREWS FROM THE PATIENT'S BONE. IT IS BELIEVED THE SCREW DAMAGED THE PATIENT'S BONE; UPON TRYING TO DRIVE A SCREW IN THE HOLE THE TEMPORARY FIXATION SCREW HAD BEEN IN, THE SCREW COULD NOT ACHIEVE ANY KIND OF PURCHASE. THEREFORE, THE SURGEONS LEFT THE HOLE EMPTY. ON THE BACK TABLE THE SCRUB TECH WAS UNABLE TO RELEASE THE TEMPORARY FIXATION SCREW FROM ONE OF THE DRIVERS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667001 90° CONTRA ANGLE DRIVER SCREWDRIVER HRS BIOMET MICROFIXATION N/A 267770

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention