BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S S BIT 5X1/8

    MDR report key: 2022895 · Received February 24, 2011

    Report

    Report Number
    1818910-2011-02637
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 27, 2011
    Manufacturer
    DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED: EVENT/PROBLEM DESCRIPTION, DATE PRODUCT REC'D BY MFG. EXAMINATION OF THE RETURNED PRODUCTS CONFIRMED THE REPORTED EVENT. A FIVE YEAR SEARCH OF THE COMPLAINT DATABASE (FOR THE RESECTION BLOCK) DID NOT SHOW ANY OTHER REPORTS AGAINST THE PRODUCT AND LOT COMBINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT: HOWEVER BASED ON THE CONDITION OF THE RETURNED RESECTION BLOCK HEAVY USAGE OVERTIME OR MISUSE CAN BE ATTRIBUTED TO THE REPORTED EVENT. 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

    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

    DURING SURGERY, A PIN WAS JAMMED INSIDE THE TIBIAL RESECTION BLOCK. THE SURGERY WAS THEN SIGNIFICANTLY PROLONGED AND THE SURGEON MUST DO THE CUT IN TWO TIMES. DURING THE SAME SURGERY, THE INTRAMEDULLAR FEMORAL 9 MM DRILL BIT RELEASED METALLIC DEBRIS DURING DRILLING WITH THE FEMORAL RESECTION BLOCK.

    Description of Event or Problem · 1

    DURING SURGERY, A PIN WAS JAMMED INSIDE THE TIBIAL RESECTION BLOCK. THE SURGERY WAS THEN SIGNIFICANTLY PROLONGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S S BIT 5X1/8 87 LXH LXH DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC. NA EK8D24

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention