BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRAUMA DRILL

    MDR report key: 2891203 · Received December 11, 2012

    Report

    Report Number
    9613350-2012-01133
    Event Type
    Other
    Date Received
    December 11, 2012
    Date of Event
    October 1, 2012
    Report Date
    November 15, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    HWE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NEITHER ARTICLE NOR LOT NUMBER IS KNOWN,THE REVIEW OF THE QUALITY RECORDS COULD NOT BE PERFORMED. THE CAUSE FOR THIS EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. HOWEVER, THERE IS NO INDICATION FOR A PRODUCT FAILURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES 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 WAS REPORTED THAT DURING SURGERY, THE DRILL BROKE WITHOUT REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAUMA DRILL UNKNOWN HWE ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other