BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING END CAP 5 MM

    MDR report key: 3842642 · Received May 16, 2014

    Report

    Report Number
    9680825-2014-00014
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 15, 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 (B)(4) 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 FOURTH COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE FOURTH COMPLAINT NOTIFIED TO US ON A TOTAL OF (B)(6) DEVICES SOLD (PLEASE KINDLY REFER ALSO TO MFR REPORTS 9680825-2014-00003, 00004, 00005). TECHNICAL EVALUATION: A TECHNICAL EVALUATION OF THE DEVICE INVOLVED WAS NOT POSSIBLE AS THE DEVICE HAS NOT YET MADE AVAILABLE. FIRST MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE EVENT WAS SENT OT OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATION. IN THIS CASE A (B)(6) MALE PATIENT HAD AN ANKLE ARTHRODESIS NAIL INSERTED ON (B)(6) 2013, FOR NON UNION IN A CHARCOT ANKLE. THE PATIENT WAS REVIEWED ON (B)(6) WITH AN X-RAY. THE ANKLE WAS DOING WELL, BUT THE END CAP WAS LOOSE NEAR THE END OF THE NAIL. WE UNDERSTAND THAT THE LOOSE END CAP WAS REMOVED AT A SECOND SURGERY ON (B)(6), AT WHICH TIME THE PROXIMAL LOCKING SCREWS (NOT SHOWN ON THE ONLY IMAGE WE HAVE) WERE REMOVED. THIS WOULD HAVE BEEN TO DYNAMISE THE NAIL AND ENCOURAGE UNION. IT IS LIKELY THAT THE PATIENT WAS GOING TO HAVE THE PROXIMAL SCREW EXTRACTION ANYWAY. WE ARE TOLD THAT THE PATIENT HAS DONE WELL. IT IS LIKELY THAT IN THIS PATIENT THE LOOSENING OF THE END CAP WILL NOT HAVE CAUSED ANY PROBLEMS. HOWEVER WE MUST ACCEPT THAT THE LOCKING OF THE DISTAL LOCKING SCREWS WITH THE END CAP WAS SEEN AS A DESIRABLE FEATURE AND THIS WAS LOST WHEN THE END CAP BECAME LOOSE, SO POTENTIALLY THE FIXATION IS NOT AS RIGID AS WE PLANNED. SECOND MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE EVENT ON (B)(6), 2014, WAS SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATION. THE SURGEON DECIDED TO REMOVE THE PROXIMAL LOCKING BOLTS TO DYNAMISE THE NAIL, AND INCREASE THE LIKELIHOOD OF UNION. WE DO NOT KNOW IF HE WOULD HAVE FELT THAT THIS WAS NECESSARY IF THE END CAP HAD REMAINED IN PLACE (AND THE DISTAL LOCKING BOLTS HAD REMAINED LOCKED TO THE NAIL). THE LOOSE END CAP WAS REMOVED AS AN INCIDENTAL PROCEDURE DURING A SECOND OPERATION, BUT IT IS POSSIBLE THAT THE INCIDENTAL PROCEDURE WAS ONLY PERFORMED BECAUSE THE END CAP HAD COME OFF. THE OPERATION WAS PERFORMED DIRECTLY BECAUSE THE PATIENT HAD A CHARCOT ANKLE SECONDARY TO DIABETES, AND THESE PATIENTS ALWAYS HAVE ADDITIONAL RISK FACTORS FOR COMPLICATIONS SUCH AS NON UNION. I AM SURE THAT THE SURGEON WOULD HAVE WANTED TO REMOVE THE END CAP ANYWAY ONCE IT WAS LOOSE, BUT HE MIGHT HAVE LEFT IT IN SITU WITH THE NAIL IF IT HAD REMAINED IN PLACE. MANUFACTURER COMMENTS: ORTHOFIX SRL HAS REQUESTED FURTHER INFORMATION ON THE EVENT TO FINALIZE THE MEDICAL EVALUATION SUCH AS DEVICE AVAILABILITY FOR THE TECHNICAL EVALUATION, PATIENT WEIGHT, DATE OF DEVICE MALFUNCTION, COPIES OF THE OPERATIVE REPORTS (INITIAL SURGERY AND REVISION ONE), COPIES OF THE PRE AND POST-OPERATIVE X-RAYS (INITIAL SURGERY AND REVISION ONE) AND INFORMATION ABOUT PATIENT CURRENT HEALTH CONDITION. 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.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATED: (B)(6). EVENT DESCRIPTION: THE END CAP BACK OUT OF NAIL AND IS LOOSE IN THE PATIENT'S HEEL. THE COMPLAINT REPORT FORM INDICATES: NO ADVERSE EFFECTS TO PATIENT; THE SURGERY WAS COMPLETED WITH DEVICE; NO CLINICALLY RELEVANT INCREASE OF THE SURGICAL PROCEDURE; AN ADDITIONAL SURGERY HAS ALREADY BEEN SCHEDULED FOR APRIL 21, 2014; COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. AN X-RAY IMAGE IS MADE AVAILABLE. INFORMATION ON PATIENT CURRENT HEALTH CONDITION: NOT AVAILABLE. ON (B)(6) 2014, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION ON THE EVENT: I SPOKE WITH THE TERRITORY MANAGER AND WAS TOLD THAT HE DID NOT ATTEND THE SURGERY ON (B)(6) 2014 AND WOULD MOST LIKELY NOT BE ABLE TO OBTAIN THE INFORMATION/PRODUCT AS REQUESTED. ON (B)(6) 2014, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION ON THE EVENT: THE TERRITORY MANAGER STATED THAT THE PATIENT HAD HEALTH ISSUES (CHARCOT) CAUSING NON-UNION. THE SURGEON REMOVED THE PROXIMAL SCREWS TO ALLOW FOR DYNAMIZATION TO PROMOTE THE HEALING PROCESS. THE TERRITORY MANAGER STATED THAT THE REMOVAL OF THE SCREWS WAS NOT RELATED TO THE COMPLAINT CONCERNING THE END CAP. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293204 LOCKING END CAP 5 MM LOCKING END CAP 5 MM HSB ORTHOFIX SRL 99-T770005 V1311329

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention