BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING END CAP 5 MM

    MDR report key: 3815643 · Received March 27, 2014

    Report

    Report Number
    9680825-2014-00005
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    November 6, 2013
    Report Date
    March 19, 2014
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HSB
    PMA / PMN Number
    K053261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS EVALUATED AS NOT REPORTABLE ON (B)(4) 2013. FOLLOWING OTHER TWO CASES OF ACN END CAP SEPARATION RECENTLY RECEIVED FROM THE SAME SURGEON, ORTHOFIX SRL DECIDES TO RE-EVALUATE ALSO THIS FIRST EVENT. 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 FIRST COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT, ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE FIRST COMPLAINT NOTIFIED TO US ON A TOTAL OF (B)(4) DEVICES SOLD (PLEASE KINDLY REFER ALSO TO MFR REPORTS 9680825-2014-00003 AND 9680825-2014-00004). TECHNICAL EVAL: A TECH EVAL OF THE DEVICE INVOLVED WAS NOT POSSIBLE AS THE DEVICE IS STILL IN USE BY PT AND THEREFORE, NOT AVAILABLE. MEDICAL EVAL: THE INFO MADE AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVA. "I AM NOT SURE THAT THIS END CAP WAS EVER SCREWED IN PROPERLY. THE VIEW THAT WE ARE GIVEN IS POOR QUALITY, BUT IT IS CLEAR THAT THERE IS A SLIGHT NARROWING BETWEEN THE END CAP AND THE NAIL. THIS PROBABLY REPRESENTS A SLIGHTLY OBLIQUE VIEW OF A PARTIALLY INSERTED 5 MM END CAP. IT IS IMPOSSIBLE TO SAY WITHOUT MORE VIEWS INCLUDING A TRUE LATERAL. I THINK THAT THIS IS MORE LIKELY AS IT IS ONLY 5.5 WEEKS SINCE THE IMPLANT WAS INSERTED. I DO NOT THINK THAT THE END CAP WOULD COME LOOSE IN THAT TIME IF IT HAD BEEN PROPERLY INSERTED. ALSO, IF THE END CAP WAS FULLY INSERTED THERE SHOULD NOT BE ANY NARROWING OF THE PROFILE BETWEEN THE CAP AND THE NAIL. SO, IT IS LIKELY THAT THE END CAP WAS NOT INSERTED FULLY, AND THE PATIENT HAD A FALL WHICH DISLODGED IT VERY SLIGHTLY. THERE WAS NO MALFUNCTION OF THE IMPLANT. IT SHOULD CAUSE NO PROBLEM IN THE IMMEDIATE FUTURE." CONCLUSION: A TECHNICAL EVALUATION OF THE DEVICE INVOLVED WAS NOT POSSIBLE AS THE DEVICE IS STILL IN USE BY PATIENT AND THEREFORE NOT AVAILABLE FOR THE TECHNICAL EVALUATION. THE MEDICAL EVALUATION EVIDENCED AS FOLLOWS: "I AM NOT SURE THAT THIS END CAP WAS EVER SCREWED IN PROPERLY. THE VIEW THAT WE ARE GIVEN IS POOR QUALITY, BUT IT IS CLEAR THAT THERE IS A SLIGHT NARROWING BETWEEN THE END CAP AND THE NAIL. THIS PROBABLY REPRESENTS A SLIGHTLY OBLIQUE VIEW OF A PARTIALLY INSERTED 5 MM END CAP. IT IS IMPOSSIBLE TO SAY WITHOUT MORE VIEWS INCLUDING A TRUE LATERAL. I THINK THAT THIS IS MORE LIKELY AS IT IS ONLY 5.5 WEEKS SINCE THE IMPLANT WAS INSERTED. I DO NOT THINK THAT THE END CAP WOULD COME LOOSE IN THAT TIME IF IT HAD BEEN PROPERLY INSERTED. ALSO, IF THE END CAP WAS FULLY INSERTED THERE SHOULD NOT BE ANY NARROWING OF THE PROFILE BETWEEN THE CAP AND THE NAIL. SO, IT IS LIKELY THAT THE END CAP WAS NOT INSERTED FULLY, AND THE PATIENT HAD A FALL WHICH DISLODGED IT VERY SLIGHTLY. THERE WAS NO MALFUNCTION OF THE IMPLANT. IT SHOULD CAUSE NO PROBLEM IN THE IMMEDIATE FUTURE." ORTHOFIX SRL HAS REQUESTED FURTHER INFORMATION ON THE EVENT TO FINALIZE THE MEDICAL EVALUATION, SUCH AS MORE X-RAYS VIEWS ESPECIALLY A POST-OPERATIVE LATERAL VIEW WITH A HIGHER QUALITY DEFINITION. UNFORTUNATELY, THIS INFORMATION WILL NOT BE MADE AVAILABLE. BASED ON THE LITTLE INFORMATION PROVIDED ON THE EVENT, IT WAS NOT POSSIBLE TO FINALIZE THE INVESTIGATION AND DETERMINE THE ROOT CAUSE OF THE EVENT NOTIFIED. ORTHOFIX SRL WOULD LIKE TO UNDERLINE THAT THE CONTRAINDICATIONS OF THE ACN SYSTEM INCLUDE THE TREATMENT OF OBESE PATIENTS (PLEASE KINDLY REFER TO THE INSTRUCTION FOR USE, REF: (B)(4)). IN CASE FURTHER INFORMATION AND/OR THE DEVICE INVOLVED BECOME AVAILABLE, ORTHOFIX SRL WILL FINALIZE THE INVESTIGATION. 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. PER TM: THE END CAP HAS SEPARATED. THE ORIGINAL SURGERY WAS ON (B)(6) 2013. X-RAYS TAKEN ON (B)(6) 2013 SHOW THE SEPARATION. PHYSICIAN BELIEVES PATIENT FELL. THE COMPLAINT REPORT FORM INDICATES: NO ADVERSE EFFECTS TO PATIENT; THE SURGERY WAS COMPLETED WITH USED DEVICE; NO CLINICALLY RELEVANT INCREASE OF THE SURGICAL PROCEDURE; NO ADDITIONAL SURGERY REQUIRED (POSSIBILITY IN THE FUTURE, IF THE END CAP IRRITATES SOFT TISSUE OF THE CALCANEUS). NOTE AND COMMENTS: END CAP APPEARS TO HAVE SEPARATED FROM THE ANKLE COMPRESSION NAIL, POSSIBLY DUE TO A PATIENT FALL. NO NEGATIVE EFFECTS HAVE ARISEN TO DATE. MANUFACTURER REFERENCE NUMBER: (B)(4). DISTRIBUTOR REFERENCE NUMBER: (B)(4). ON (B)(4) 2014, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION ON THE EVENT: LOT OF THE END CAP INVOLVED: V1311329. NO MORE X-RAYS WILL BE MADE AVAILABLE. PATIENT IS DOING MUCH BETTER. TM WILL SEND CURRENT OFFICE NOTE. THE SYSTEM IS STILL IN USE BY PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179641 LOCKING END CAP 5 MM LOCKING END CAP 5 MM - HSB, JDS HSB ORTHOFIX SRL 99-T770005 V1311329

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR