BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL RESECTION BLOCK 7 DEG

    MDR report key: 2022898 · Received February 24, 2011

    Report

    Report Number
    1818910-2011-01702
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    November 18, 2010
    Report Date
    January 26, 2011
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 COMBINATION. A REVIEW OF THE DEVISE HISTORY REPORT DID NOT REVEAL ANY ANOMALIES REGARDING THE REPORTED EVENT AGAINST THE PRODUCT AND LOT COMBINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT: HOWEVER PATIENT ACTIVITY AND CONTRAINDICATIONS COULD BE ATTRIBUTED TO THE REPORTED FRACTURE. 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, THE SURGEON FIXED THE RESECTION BLOCK BUT A PIN JAMMED INSIDE IT. IT WAS IMPOSSIBLE TO REMOVE THE PIN FROM THE RESECTION BLOCK. THE SURGERY WAS SIGNIFICANTLY PROLONGED. UPDATED INFORMATION (B)(6) 2011: SURGERY DELAY WAS 40 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIBIAL RESECTION BLOCK 7 DEG 87 LXH LXH DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS NA AH0502

    Patients

    Seq Age Sex Outcome Treatment
    1 NA