BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHORT CM LAG SCREW REAMER

    MDR report key: 3122321 · Received April 17, 2013

    Report

    Report Number
    9613350-2013-01495
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 31, 2013
    Report Date
    March 31, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    HTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE THE INSTRUMENT, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THOUGH THE CAUSE FOR THE SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. WHEN THE INSTRUMENT HAS BEEN RECEIVED AND RESULT OF THE EVAL IS MADE AVAILABLE, AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CMN NAIL IMPLANTATION, THE SURGEON HAD TO USE TWO LAG SCREW GUIDE WIRES ON DIFFERENT OCCASION SINCE ON THE FIRST ATTEMPT THE SURGEON COULD NOT LOCATE THE CENTER OF THE HEAD. WHEN THE SURGEON WAS REMAINED USING THE SECOND GUIDE WIRE, THE TIP OF THE REAM "STUTTERED AND STOPPED". THE SURGEON PULLED THE REAMER OUT AND FOUND PART OF THE TIP HAD BROKEN OFF. AN X-RAY PICTURE HAD SHOWN THAT ACTUALLY THE TIP OF THE FIRST GUIDE WIRE HAD BROKEN OFF CAUSING THE REAMER TO BREAK. THE BROKEN TIP WAS RETRIEVED AND THE SURGERY WAS COMPLETED SUCCESSFULLY USING ANOTHER REAMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166313 SHORT CM LAG SCREW REAMER SHORT CM LAG SCREW REAMER HTO ZIMMER GMBH 11.616492

    Patients

    Seq Age Sex Outcome Treatment
    1 Other