BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING END CAP 5 MM

    MDR report key: 3733688 · Received March 27, 2014

    Report

    Report Number
    9680825-2014-00003
    Event Type
    Injury
    Date Received
    March 27, 2014
    Date of Event
    December 10, 2013
    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 HAV 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 THE ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE SECOND COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE SECOND COMPLAINT NOTIFIED TO US ON A TOTAL OF (B)(4) DEVICES SOLD (PLEASE KINDLY REFER ALSO TO MFR REPORTS 9680825-2014-0004 AND 9680825-2014-00005). A TECHNICAL EVALUATION OF THE DEVICE INVOLVED WAS NOT POSSIBLE AS THE DEVICE HAS NOT YET MADE AVAILABLE. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE EVENT TOGETHER WITH A COPY OF THE OPERATIVE REPORT AND THE XRAYS WERE SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF MEDICAL EVALUATION. " THIS PT HAD COMPLICATED HISTORY WITH DIABETIC PERIPHERAL NEUROPATHY LEADING TO A CHARCOT ANKLE. THE ANKLE ARTHRODESIS NAIL WAS INSERTED IN AN UNEVENTFUL PROCEDURE. AS DESCRIBED THE OPERATION AND THE PROCEDURE ARE ENTIRELY APPROPRIATE FOR THIS PT'S CONDITION. AT OPERATION ON (B)(6) 2013, THE END CAP OF THE ARTHRODES NAIL WAS INSERTED CORRECTLY, AND LOOKS AS IT SHOULD ON THE X-RAY OF THE TIME, WHICH IS AN IMAGE INTENSIFIER VIEW PRESUMABLY INTRAOPERATIVELY. EXACTLY 6 WEEKS LATER, AN X-RAY SHOWED THAT THE END CAP HAD SEPARATED. IT WAS REMOVED THAT DAY TOGETHER WITH ONE OF THE TRANSVERSE SCREWS, THE DISTAL ONE, WHICH LOOKS AS THOUGH IT MAYBE EXTRUDING IN THE IMAGE (BUT AN AP FILM IS REQUIRED TO CONFIRM THIS). THERE IS NO OBVIOUS REASON FOR THIS. THE MOST LIKELY REASON IS THE ONE SUGGEST BY THE SURGEON, THAT THE PT HAS BEEN WEIGHTBEARING. IN A CHARCOT ANKLE, IT IS IMPOSSIBLE FOR THE PT TO BE AWARE OF HOW MUCH LOAD HE IS PUTTING THE LEG WITH WEIGHTBEARING, AND THE USUAL RESULT IS EXCESSIVE LOADING WHICH IS NOT A GOOD IDEA POSTOPERATIVELY, WHEN THE ANKLE IS SO DISEASED ANYWAY. IT HIGHLY LIKELY THAT THIS PT WAS LOADING HIS ANKLE MORE THAN ADVISED AND THIS IS THE REASON FOR END CAP AND LOCKING SCREW EXTRUSION. THIS PT SHOULD COME TO NO HARM PROVIDED HE OBEYS INSTRUCTIONS." ORTHOFIX SRL HAS REQUESTED FURTHER INFORMATION ON THE EVENT SUCH AS AN AP XRAY, COPIES OF THE REVISION SURGERY OPERATIVE REPORT, CODE AND LOT OF THE LOCKING SCREW THAT WAS REMOVED AND DEVICES AVAILABILITY FOR THE TECHNICAL EVALUATION. UNFORTUNATELY, THIS INFORMATION HAS NOT YET MADE AVAILABLE. AS SOON AS FURTHER INFORMATION AND/OR THE RESULTS OF THE INVESTIGATION WILL BE AVAILABLE, ORTHOFIX SRL WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) HOSPITAL; SURGEON NAME: DR (B)(6); DATE OF SURGERY: (B)(6) 2013. THE END CAP SEPARATED FROM THE RETROGRADE ANGLE COMPRESSION NAIL. THE ORIGINAL SURGERY WAS ON (B)(6) 2013. X-RAYS WERE TAKEN ON (B)(6) 2013 SHOWING THE DISTINCT SEPARATION OF THE END CAP FROM THE NAIL. PHYSICIAN REMOVED END CAP AND LATERAL-MEDICAL CALCANEAL SCREW IN THE HOSPITAL WOUND CARE CENTER ON (B)(6) 2013. PT HAS DIABETIC NEUROPATHY AND POOR BONE QUALITY, AND MAY HAVE BEEN PREMATURELY WEIGHT BEARING. THE COMPLAINT REPORT FORM INDICATES: THE DEVICE FAILURE CAUSED ADVERSE EFFECTS TO PT; THE SURGERY WAS COMPLETED WITH USED DEVICE; NO CLINICALLY RELEVANT INCREASE OF THE SURGICAL PROCEDURE; AN ADDITIONAL SURGERY WAS REQUIRED; COPIES OF OPERATIVE REPORT AND COPIES OF X-RAY IMAGES ARE AVAILABLE. ON (B)(6) 2014, ORTHOFIX SRL RECEIVED THE FOLLOWING INFORMATION: THE REPORT STATES THAT THE REMOVAL OF THE END CAP AND SCREWS WAS DONE ON (B)(6) 2013. I HAVE REQUESTED THE DEVICES THAT WERE REMOVED AND THE OP REPORT CONCERNING THAT REMOVAL. THE END CAP PART NUMBER INVOLVED IS 99-T770005 LOT V1311329. I HAVE REQUESTED THE AP X-RAY FROM THE TM AS WELL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179566 LOCKING END CAP 5 MM LOCKING END CAP 5 MM HSB ORTHOFIX SRL 99-T770005 V1311329

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention