BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA SHORT STRUT TL-HEX - 45MM-101MM

    MDR report key: 5610754 · Received April 27, 2016

    Report

    Report Number
    9680825-2016-00036
    Event Type
    Injury
    Date Received
    April 27, 2016
    Report Date
    April 22, 2016
    Manufacturer
    ORTHOFIX SRL
    Product Code
    KTT
    PMA / PMN Number
    K152171
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 50-10100 BATCH V1367977 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2014, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX (B)(4) HISTORICAL RECORDS, NO OTHER SIMILAR NOTIFICATIONS HAVE BEEN RECEIVED ON THIS SPECIFIC DEVICE CODE. TECHNICAL EVALUATION: A TECHNICAL EVALUATION OF THE DEVICES INVOLVED WAS NOT POSSIBLE AS THE FRAME IS STILL IN USE BY PATIENT AND THEREFORE NOT AVAILABLE FOR THE TECHNICAL EVALUATION. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICES CURRENTLY IN USE BECOME AVAILABLE. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATION PERFORMED. "THIS (B)(6) MALE PATIENT WAS HAVING A CORRECTION TO THE FOOT WITH THE TL-HEX SYSTEM. 7 WEEKS INTO TREATMENT THE MOTHER NOTICED THAT STRUTS 5 & 6 HAD POPPED OUT OF THE RING. AFTER IMMEDIATE TEMPORARY RELOCATION WITH ZIP TIES THE STRUTS WERE LOCKED INTO POSITION BY THE REPRESENTATIVE WITH A TORQUE WRENCH. THE PATIENT CAME TO NO HARM". FINAL COMMENTS: A TECHNICAL EVALUATION OF THE DEVICES INVOLVED WAS NOT POSSIBLE AS THE FRAME IS STILL IN USE BY PATIENT AND THEREFORE NOT AVAILABLE FOR THE TECHNICAL EVALUATION. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICES CURRENTLY IN USE BECOME AVAILABLE. THE MEDICAL EVALUATION EVIDENCED AS FOLLOW: "THIS (B)(6) MALE PATIENT WAS HAVING A CORRECTION TO THE FOOT WITH THE TL-HEX SYSTEM. 7 WEEKS INTO TREATMENT THE MOTHER NOTICED THAT STRUTS 5 & 6 HAD POPPED OUT OF THE RING. AFTER IMMEDIATE TEMPORARY RELOCATION WITH ZIP TIES THE STRUTS WERE LOCKED INTO POSITION BY THE REPRESENTATIVE WITH A TORQUE WRENCH. THE PATIENT CAME TO NO HARM". A COMPLETE MEDICAL EVALUATION OF THE CASE WAS NOT PERFORMED AS SOME INFORMATION ABOUT THE MEDICAL PROCEDURE, WAS NOT MADE AVAILABLE, I.E. COPIES OF THE OPERATIVE REPORT, COPIES OF THE PRE AND POST-OPERATIVE X-RAYS AND THE DEVICES AVAILABILITY FOR THE TECHNICAL EVALUATION. BASED ON THE INFORMATION AVAILABLE ON THE EVENT, IT WAS NOT POSSIBLE TO FINALIZE THE INVESTIGATION AND DETERMINE THE ROOT CAUSE OF THE EVENT NOTIFIED. IF FURTHER INFORMATION AND/OR THE DEVICES INVOLVED BECOME AVAILABLE, ORTHOFIX (B)(4) WILL FINALIZE THE INVESTIGATION. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00035 AND 9680825-2016-00037. DEVICE CURRENTLY IN USE BY PATIENT.

    Description of Event or Problem · 1

    THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATED: HOSPITAL NAME: (B)(6). SURGEON NAME: DR. (B)(6). DATE OF SURGERY: (B)(6) 2016. BODY PART TO WHICH DEVICE WAS APPLIED: FOOT. SURGERY DESCRIPTION: CORRECTION. PATIENT INFORMATION: (B)(6), MALE. PROBLEM OBSERVED DURING : INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: 7 WEEKS DURING THE TREATMENT THE LOCKING SET SCREW WAS LOOSENED. AS A RESULT THE STRUT NO. 5 AND 6 DROPPED OUT OF THE TL-HEX RING. THE MOTHER OF THE PATIENT WAS ABLE TO RE-INSERT THE STRUTS IMMEDIATELY. THE MOTHER TEMPORARILY FIXED THE STRUTS AT THE RING WITH ZIP-TIES. TODAY THE LOCAL SALES REP WAS ABLE TO RE-TIGHTEN THE SET SCREW WITH THE TORQUE WRENCH. THE TL-HEX IS STILL MOUNTED. THUS, NO ITEM CAN BE PROVIDED FOR FURTHER INVESTIGATION. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS TO PATIENT; THE INITIAL SURGERY WAS COMPLETED WITH USED DEVICE; THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE; AN ADDITIONAL SURGERY WAS NOT REQUIRED; COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE; COPIES OF THE X-RAYS IMAGES ARE NOT AVAILABLE; PATIENT CURRENT HEALTH CONDITION: GOOD; NOTE AND COMMENTS: THE TL-HEX FRAME IS STILL MOUNTED. PROCEDURE IS GOING ON. ON APRIL 8, 2016, ORTHOFIX (B)(4) RECEIVED THE FOLLOWING INFORMATION FROM THE LOCAL DISTRIBUTOR: NOW WE RECEIVED THE BATCH NUMBER AND ITEM CODE REGARDING THE COMPLAINT (B)(4): CODE 56-21400 BATCH V1405777; CODE 50-10100 BATCH V1367977; CODE 50-10400 BATCH V1409898. PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2016-00035 AND 9680825-2016-00037. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266533 ULTRA SHORT STRUT TL-HEX - 45MM-101MM ULTRA SHORT STRUT TL-HEX - 45MM-101MM KTT ORTHOFIX SRL 50-10100 V1367977

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention