BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP2 TIBIAL RADEL IMPACTOR

    MDR report key: 3771279 · Received April 24, 2014

    Report

    Report Number
    1818910-2014-17443
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    DEPUY-RAYNHAM 1219655
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED IMPACTOR CONFIRMED THE FRACTURE INITIATION ALONG THE SLOT THAT CONNECTS WITH THE UNIVERSAL HANDLE. THE ROOT CAUSE IS ATTRIBUTED TO MISUSE THROUGH MISALIGNMENT. THE FLAT OF THE IMPACTOR EXHIBITS GOUGING INDICATING THE IMPACTOR WAS NOT PROPERLY ALIGNED PRIOR TO IMPACTION. NO EVIDENCE WAS FOUND INDICATING PRODUCT ERROR WAS A CONTRIBUTING FACTOR. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. MONITOR THROUGH TREND ANALYSIS. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED FOR EVALUATION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. PATIENT X-RAYS WERE PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED ANOMALIES. BASED ON THE INFORMATION RECEIVED AND INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE NEED FOR REVISION IS UNKNOWN. IT IS NOT POSSIBLE TO DETERMINE IF THERE WAS A MANUFACTURING FAULT. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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

    PROCEDURE: TOTAL KNEE REPLACEMENT ON (B)(6) 2014. THE INSTRUMENT HAS A CRACKED. THE CRACKED DID NOT PROPAGATE ANY FURTHER. USED A SAME LIKE A PRODUCT TO COMPLETE THE CASE. THERE WAS NO DELAY DURING THE PROCEDURE. NO AE TO THE PATIENT. NO MEDICAL REPORTS OR OPERATIVE NOTES AVAILABLE. NO PHOTO OR X-RAY AVAILABLE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249389 SP2 TIBIAL RADEL IMPACTOR KNEE INSTRUMENT/TRIAL LXH DEPUY-RAYNHAM 1219655 J0407

    Patients

    Seq Age Sex Outcome Treatment
    1