BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSANAIL CANCELLOUS SCREW

    MDR report key: 2252414 · Received September 17, 2011

    Report

    Report Number
    1818910-2011-16477
    Event Type
    Injury
    Date Received
    September 17, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 20, 2011
    Manufacturer
    DEPUY WARSAW
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A DEPUY (B)(4) REVIEWED THE PROVIDED X-RAYS AND DETERMINED TO BE PRE-OP AND DO NOT SHOW OR CONFIRM THE FRACTURED IMPLANT. REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO MANUFACTURING DEVIATIONS OR ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THIS PART AND LOT NUMBER COMBINATION. REVIEW OF THE LIMITED MEDICAL RECORDS FOUND HER LAST POST-OP CHECKUP WAS ON (B)(6), 2007 AND THE SURGEON STATES SHE WAS DOING WELL. THE PATIENT VISITED THE DOCTOR ON (B)(6), 2010; THE SURGEON COMMENTED THAT HE HAD NOT SEEN HER SINCE 2007 AND NOW HAD A DEFORMITY AND THE FINGER ROTATES INSTEAD OF FLEXING. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO A PAIN AND IMPINGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSANAIL CANCELLOUS SCREW TRAUMA FIXATION DEVICE HSB DEPUY WARSAW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention