BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90° CONTRA ANGLE DRIVER

    MDR report key: 7800895 · Received August 21, 2018

    Report

    Report Number
    0001032347-2018-00558
    Event Type
    Malfunction
    Date Received
    August 21, 2018
    Date of Event
    July 23, 2018
    Report Date
    January 30, 2019
    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

    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# 267550) WERE VISUALLY EVALUATED. THE DRIVER SHOWED SIGNS OF MODERATE USE WITH SOME MINOR DISCOLORATION ON THE HANDLE AND THE KNOB. THE FIXATION SCREW ALSO SHOWED SIGNS OF USE, AS IT HAD DAMAGE TO THE THREADS. FUNCTIONAL TESTING WAS DONE BY ATTEMPTING TO REMOVE THE SCREW FROM THE DRIVER. THE SCREW COULD NOT BE REMOVED. THE DRIVER WAS DISASSEMBLED FOR FURTHER INSPECTION. WHEN THE COVER OF THE HEAD ASSEMBLY WAS REMOVED, IT WAS NOTED THAT THE SCREW HAD ROTATED INSIDE THE DRIVER COLLET AND GOT CAUGHT ON THE SLOT ON THE END OF THE PIN THAT MATES WITH THE DRIVER. IT COULD NOT BE REMOVED WITHOUT BEING ROTATED PRIOR TO PULLING IT OUT. WEAR WAS OBSERVED ON THE MATING SURFACES OF THE SCREW AND THE DRIVER COLLET. 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 FORCE WAS APPLIED, BEYOND WHAT IS REQUIRED TO PURCHASE THE BONE, WHICH CAUSE DEFORMATION ON THE PIN AND COLLET, CAUSING EXCESS CLEARANCE FOR THE PIN TO ROTATE AND GET CAUGHT. 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: 0001032347-2018-00559-2.

    Additional Manufacturer Narrative · 0

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2018-00559-1.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PROCEDURE WAS COMPLETED BY OPENING ANOTHER SET.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: BIOMET MICROFIXATION RIBFIX BLU SYSTEM TEMPORARY FIXATION SCREW, CONTRA ANGLE, 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: 0001032347-2018-00559.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TEMPORARY FIXATION PIN BECAME IRREVERSIBLY LODGED IN THE RIGHT ANGLE SCREWDRIVER. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641662 90° CONTRA ANGLE DRIVER SCREWDRIVER HRS BIOMET MICROFIXATION N/A 191750

    Patients

    Seq Age Sex Outcome Treatment
    1