BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACN LOCKING SCREW

    MDR report key: 3732788 · Received March 27, 2014

    Report

    Report Number
    9680825-2014-00006
    Event Type
    Death
    Date Received
    March 27, 2014
    Date of Event
    February 11, 2014
    Report Date
    March 19, 2014
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HSB
    PMA / PMN Number
    K053261
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO INCLUDED IN THE OPERATIVE REPORT OF THE REVISION SURGERY PERFORMED ON (B)(6) 2014 INDICATES PRESENCE OF A BROKEN SCREW. TECHNICAL EVALUATION: A TECHNICAL EVALUATION OF THE BROKEN LOCKING SCREW WAS NOT POSSIBLE AS THE DEVICE HAS NOT YET MADE AVAILABLE FOR THE INVESTIGATION. UNFORTUNATELY, NO INFO ABOUT DEVICE CODE AND LOT INVOLVED IS AVAILABLE, THEREFORE IT IS NOT POSSIBLE TO PERFORM ANY TECHNICAL INVESTIGATION OR REVIEW OF THE HISTORICAL DATA ON THE SPECIFIC PRODUCTION BATCH. THE MEDICAL EVALUATIONS PERFORMED AND THE MANUFACTURER COMMENTS ARE PROVIDED. (PLEASE KINDLY REFER TO "MEDICAL EVALUATIONS AND MANUFACTURER COMMENTS TO MFR REPORTS # 9680825-2014-00004.")

    Description of Event or Problem · 1

    THE INFO PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) HOSPITAL; SURGEON NAME: DR (B)(6); DATE OF SURGERY: (B)(6) 2013; DATE OF REVISION SURGERY: (B)(6) 2014. THE END CAP SEPARATED FROM THE BASE OF THE NAIL ABOUT 2 MONTHS AFTER INSERTION. THE PATIENT THEN DEVELOPED A LARGE DIABETIC SKIN ULCER, AND BECAME SEPTIC. I WILL HAVE TO SPEAK WITH DR (B)(6) TODAY ABOUT THE PATIENT'S CURRENT HEALTH AND LEG STATUS. THE LAST TIME WE SPOKE, THE PATIENT HAD BEEN IN AN INDUCED COMA AND A BELOW THE KNEE AMPUTATION WAS LIKELY. THE COMPLAINT REPORT FORM INDICATES: THE DEVICE FAILURE CAUSED ADVERSE EFFECTS TO PATIENT; THE SURGERY WAS COMPLETED WITH USED DEVICE; NO CLINICALLY RELEVANT INCREASE OF THE SURGICAL PROCEDURE; AN ADDITIONAL SURGERY WAS REQUIRED; COPIES OF THE OPERATIVE REPORT AND COPIES OF X-RAY IMAGES ARE AVAILABLE. ON (B)(4) 2014, ORTHOFIX SRL REC'D THE FOLLOWING ADDITIONAL INFO: THE PATIENT PASSED AWAY ON SATURDAY (B)(6) 2014; THE END CAP WAS NOT REMOVED BUT FELL OUT OF THE PATIENT'S FOOT AND THAT IS WHEN SHE WENT BACK IN FOR FULL HARDWARE REMOVAL; THE TM ALSO STATED THAT THE PATIENT NOR DOCTOR WERE AWARE THAT THE END CAP HAD LOOSENED UNIT IT FELL OUT; THE PRODUCT IS BEING HELD BY THE HOSPITAL AND WOULD ONLY RELEASE UNDER PATIENT'S CONSENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179421 ACN LOCKING SCREW ACN LOCKING SCREW HSB ORTHOFIX SRL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death| R