BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDCAP UNIVERSAL FLUSH

    MDR report key: 2141446 · Received June 22, 2011

    Report

    Report Number
    1818910-2011-08530
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 26, 2011
    Manufacturer
    DEPUY ACE S.A. 'R.L.
    Product Code
    HSB
    PMA / PMN Number
    K033329
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    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

    DEPUY (B)(4). REPORTS THAT A UNIVERSAL FLUSH ENDCAP ((B)(4)) COULD NOT BE REMOVED FROM AN UNSPECIFIED VERSANAIL TIBIAL NAIL ((B)(4)). THE COMPLAINT IS NOT VERIFIABLE SINCE THE PRODUCT WAS NOT RETURNED BUT IS CONSIDERED VALID AND CONFIRMED. HOWEVER, SINCE THE PRODUCT WAS NOT RETURNED SO THERE IS NO WAY TO DETERMINE IF PRODUCT HAD A SPECIFIC DEFECT. DIFFICULTY IN REMOVING THE ENDCAP FROM IMPLANTED NAILS IS A RECOGNIZED HAZARD. THE RISK MANAGEMENT REPORT ((B)(4)) AND DFMEA ((B)(4)) ASSIGN AN OCCURRENCE RATE OF (B)(4) FOR THIS EVENT. AS STATED IN (B)(4), REMOVAL DIFFICULTIES ARISE DUE TO CROSS THREADING FROM INSERTION OR DIFFICULTY CLEARING THE HEX FROM BONE GROWTH. THE TREND OF REPORTED REMOVAL DIFFICULTIES HAS REMAINED CONSTANT SINCE PRODUCT RELEASE IN 2006. BASED ON THE STEADY TREND, THERE IS NO EVIDENCE OF A SYSTEMATIC MANUFACTURING RELATED ROOT CAUSE. TREND IS INDICATIVE OF A CONSISTENT RESIDUAL RISK OF NON-REMOVAL. PRODUCT WAS NOT RETURNED SO THERE IS NO WAY TO DETERMINE IF PRODUCT HAD A DEFECT. THE ASSUMPTION MUST BE THAT THE ROOT CAUSE IS EITHER ENTRAPPED BIOLOGICAL MATERIAL OR THAT THE ENDCAP IS CROSSTHREADED IN THE NAIL. NO CORRECTIVE ACTION IS INDICATED AT THIS TIME. THE COMPLAINT TREND IS STEADY. COMPLAINTS WILL CONTINUE TO BE MONITORED. 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 END CAP COULD NOT BE REMOVED AND WAS LEFT IN THE PATIENT'S BODY IN REVISION SURGERY ON (B)(6) 2011. DOI UNKNOWN. THE DEVICE WAS IMPLANTED WITH VERSA NAIL TIBIA FOR THE FRACTURE OF THE SHAFT OF TIBIA. DATE OF IMPLANTATION WAS UNKNOWN. ON (B)(6), REVISION SURGERY WAS DONE AS THE FRACTURE WAS HEALED. DURING THE SURGERY, THE END CAP COULD NOT BE REMOVED. ALTHOUGH IT TOOK 60 MINUTES TO TRY TO REMOVE IT, THE END CAP COULD NOT BE REMOVED FROM THE PATIENT. ONLY SCREW WAS REMOVED AND THE END CAP WAS LEFT IN THE PATIENT TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDCAP UNIVERSAL FLUSH 87HSB HSB DEPUY ACE S.A. 'R.L. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR