BEUDAMED
    FDA Adverse Event Other Summary report: N

    STER TROC NAIL 135 DEG X 9MM

    MDR report key: 1941936 · Received December 20, 2010

    Report

    Report Number
    1818910-2010-10308
    Event Type
    Other
    Date Received
    December 20, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSB
    PMA / PMN Number
    MM 33-38
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THIS PART AND LOT NUMBER COMBINATION. REVIEW OF THE AS400 SYSTEM SHOW THAT 6 OTHER DEVICES FROM LOT DJJBML HAVE BEEN DELIVERED AND CAN BE REASONABLY CONCLUDED IMPLANTED WITHOUT ISSUE AS NO FURTHER REPORTS ARE IDENTIFIED. 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

    EXAMINATION OF THE RETURNED PRODUCT CONFIRMED THE NAIL WAS BENT IN TWO ANGLES. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR BENT NAILS FOR THIS PRODUCT AND LOT CODE. REVIEW OF THE (B)(4) SYSTEM SHOW THAT EIGHT OTHER DEVICES FROM THE REPORTED LOT HAVE BEEN DELIVERED AND CAN BE REASONABLY CONCLUDED IMPLANTED WITHOUT ISSUE AS NO FURTHER REPORTS ARE IDENTIFIED. (B)(4), THE MANUFACTURING FACILITY, REVIEWED THE INCOMING MATERIAL RECORDS AND CONFIRMED THE TITANIUM CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO PRODUCTION. THE REVIEW OF THE HISTORY DEVICE RECORDS WAS PERFORMED AND CONFIRMED THE PRODUCT CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. A DEPUY (B)(4) MATERIAL RESEARCH SCIENTIST EXAMINED THE NAIL AND STATED A BENDING LOAD WAS APPLIED TO THE NAIL, WITH PEAK BENDING MOMENT IN THE REGION OF THE DISTAL SLOT AND HOLE THAT EXCEEDED THE YIELD STRENGTH OF THE MATERIAL RESULTING IN PLASTIC DEFORMATION. THERE IS NO OBVIOUS PRODUCT OR MATERIAL CONTRIBUTION TO THE FAILURE (BENDING) OF THIS NAIL. 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.

    Description of Event or Problem · 1

    THE TROCHANTERIC NAIL BENT UPON INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STER TROC NAIL 135 DEG X 9MM 87HSB HSB DEPUY ORTHOPAEDICS, INC. NA DJJBML

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization