BEUDAMED
    FDA Adverse Event Injury Summary report: N

    P.F.C. FLUT TIB ROD 150X12MM

    MDR report key: 2211700 · Received August 10, 2011

    Report

    Report Number
    1818910-2011-13608
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 12, 2011
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K882234
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED PRODUCTS CONFIRMED THE REPORTED EVENT. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE PRODUCT AND LOT COMBINATIONS. UNABLE TO OBTAIN THE DHR BASED ON THE REPORTED LOT CODE COULD NOT BE VERIFIED AS VALID. IT WAS NOT LEGIBLE ON THE RETURNED SAMPLE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT: HOWEVER EVIDENCE CONFIRMED THAT THE TIBIAL ROD FRACTURE WAS CAUSED BY FATIGUE. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    UPDATE (B)(4) 2012: RE-OPENED TO REVIEW THE PROVIDED X-RAYS. REVIEW OF THE PROVIDED X-RAYS BY WARSAW CUSTOMER QUALITY MEDICAL PROFESSIONAL CONFIRMED THE REPORTED FRACTURE. NO OTHER OBSERVATIONS OR CONCLUSION COULD BE MADE. SHOULD 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

    REVISED DUE TO FEMORAL FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 P.F.C. FLUT TIB ROD 150X12MM 87JWH JWH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA 35164R

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention