BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSANAIL 10MMX20CM STERILE

    MDR report key: 2151230 · Received June 30, 2011

    Report

    Report Number
    1818910-2011-11926
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    DEPUY ACE S.A.'R.L.
    Product Code
    HSB
    PMA / PMN Number
    K023115
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND X-RAYS ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. PROVIDED INFO STATES THE PRODUCT WAS IMPLANTED IN FEBRUARY OF 2011 AND EXPLANTED ON (B)(6), 2011. ALTHOUGH THE COMPLAINT IS NON-VERIFIABLE, WEIGHT BEARING TOO SOON MAY BE A CONTRIBUTING FACTOR. IN THE WARNINGS AND PRECAUTIONS SECTION OF THE SURGICAL TECHNIQUE STATES "THESE IMPLANTS ARE INTENDED AS A GUIDE TO NORMAL HEALING AND ARE NOT INTENDED TO REPLACE NORMAL BODY STRUCTURE OR BEAR THE WEIGHT OF THE BODY IN THE PRESENCE OF INCOMPLETE BONE HEALING. DELAYED UNIONS OR NONUNIONS IN THE PRESENCE OF LOAD BEARING OR WEIGHT BEARING MIGHT EVENTUALLY CAUSE THE IMPLANT TO BREAK DUE TO METAL FATIGUE." (B)(4), THE MFG FACILITY, REVIEWED THE DEVICE HISTORY RECORDS AND FOUND NO MFG DEVIATIONS OR ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THIS PART AND LOT NUMBER COMBINATION. REVIEW OF THE (B)(4) SYSTEM SHOW THAT SIX OTHER DEVICES FROM THE REPORTED LOT HAVE BEEN DELIVERED OR INVOICED AND CAN BE REASONABLY CONCLUDED IMPLANTED W/O ISSUE AS NO FURTHER REPORTS ARE IDENTIFIED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFO PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADD'L INFO BE REC'D TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT REVISED TO ADDRESS BROKEN NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSANAIL 10MMX20CM STERILE 87 HSB HSB DEPUY ACE S.A.'R.L. NA DLKBWO

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention