BEUDAMED
    FDA Adverse Event Death Summary report: N

    LOCKING END CAP 5 MM

    MDR report key: 3732789 · Received March 27, 2014

    Report

    Report Number
    9680825-2014-00004
    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

    ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE CODE 99-T770005, LOT V1311329 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2012, WAS COMPRISED OF (B)(4)END CAPS. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE THIRD COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT. ACCORDING TO ORTHFIX SRL HISTORICAL RECORDS, THIS IS THE THIRD COMPLAINT NOTIFIED TO US ON A TOTAL OF (B)(4) DEVICES SOLD (PLEASE KINDLY REFER ALSO TO MFR REPORTS 9680825-2014-00003 AND 9680825-2014-00005). TECHNICAL EVALUATION: A TECHNICAL EVALUATION OF THE DEVICE INVOLVED WAS NOT POSSIBLE AS THE DEVICE HAS NOT YET MADE AVAILABLE. 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 AND 9680825-2014-00006").

    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)(6) 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
    179323 LOCKING END CAP 5 MM LOCKINGE ND CAP 5 MM HSB ORTHOFIX SRL 99-T770005 V1311329

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death| R