BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE SHAFT (TRI-SHANK)

    MDR report key: 3172341 · Received June 5, 2013

    Report

    Report Number
    9613350-2013-01616
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE THE INSTRUMENT. NO HARM TO THE PT OCCURRED, AS THE CASE DEALS WITH AN INSTRUMENT AND AS THE SURGERY WAS COMPLETED WITH ANOTHER INSTRUMENT SET. SHOULD ADD'L INFO, THE CHANGE THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON WAS USING THE CONTINUUM DRILL GUIDE (INSTRUMENT) WITH THE CONTINUUM FLEXIBLE DRILL SHAFT (INSTRUMENT) THAT HAD THE APPROPRIATE 30 MM DRILL BIT ATTACHED AND ATTEMPTED TO DRILL FOR A SCREW THROUGH A HOLE IN A CLUSTER HOLE CONTINUUM SHELL. HOWEVER, AS HE STARTED TO DRILL THE HOLE THE SHAFT BROKE INTO TWO PIECES. A SECOND CONTINUUM SET WAS THEN USED IN ORDER TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249152 FLEXIBLE SHAFT (TRI-SHANK) CONTINUUM FLEXIBLE SHAFT KWA ZIMMER GMBH 09465317

    Patients

    Seq Age Sex Outcome Treatment
    1