BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANKLE TRANSFIX PIN STERILE KIT

    MDR report key: 11390917 · Received February 28, 2021

    Report

    Report Number
    9680825-2021-00016
    Event Type
    Injury
    Date Received
    February 28, 2021
    Date of Event
    January 25, 2021
    Report Date
    May 5, 2021
    Manufacturer
    ORTHOFIX SRL
    Product Code
    KTT
    UDI-DI
    18054242511298
    PMA / PMN Number
    K113770
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF HISTORICAL RECORDS FROM THE DEVICES RETURNED ON MARCH 2, 2021, IT WAS DETERMINED THAT THEY BELONG TO THE STERILE KIT CODE 99-93503US BATCH B1476140 INSTEAD OF THE COMPLAINED STERILE KIT CODE 99-93502US BATCH B1384578. PLEASE FIND BELOW THE HISTORICAL DATA. ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE STERILE KIT CODE 99-93503US BATCH B1476140 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2020, WAS COMPRISED OF 28 KITS. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION: ON MARCH 2, 2021, ORTHOFIX SRL RECEIVED THE FOLLOWING ITEMS: PRODUCT CODE: PRODUCT DESCRIPTION: BATCH NUMBER: QUANTITY: 93010, LARGE CLAMP, B1472258, 6, 932300, ROD D 12 MM L 300 MM, 0319, 2, 932200, ROD D 12 MM L 200 MM, 0319, 1, FROM THE VERIFICATION OF THE BATCH NUMBERS OF THE DEVICES RETURNED, IT WAS DETERMINED THAT THEY BELONG TO THE STERILE KIT CODE 99-93503US BATCH B1476140 INSTEAD OF THE COMPLAINED STERILE KIT CODE 99-93502US BATCH B1384578. THE RETURNED DEVICES WERE SUBJECTED TO VISUAL, DIMENSIONAL AND FUNCTIONAL CHECK AS PER ORTHOFIX SRL SPECIFICATION. THE VISUAL CHECK EVIDENCED AS FOLLOWS: 1). ALL CLAMPS DID NOT EVIDENCE ANY VISUAL DAMAGE. 2). ONE BAR CODE 932300 DID NOT EVIDENCE ANY VISUAL DAMAGE (MARKING STILL VISIBLE). 3). THE REMAINING TWO BARS SHOWN FADED MARKING. THE DIMENSIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES. ALSO THE FUNCTIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES. THE CLAMPS WERE FUNCTIONALLY TESTED FOR THE FOLLOWING FEATURES: - CLOSURE MECHANISM; - MOVEMENT OF THE INTERNAL TEETH ALONG THE THREAD; - NO DISASSEMBLING OF THE CLAMP; - NO DISASSEMBLING OF THE ECCENTRIC. ALL CLAMPS MEET THE SPECIFICATIONS. IT WAS ALSO VERIFIED IF THE CLAMPS PROPERLY BLOCKED THE SCREW AND THE ROD BY USING THE CORRECT CLOSURE PROCEDURE. ALL CLAMPS MEET THE SPECIFICATIONS. A FURTHER TEST TO VERIFY THE SLIPPING TORQUE CONFIRMED THAT THE CLAMPS PERFORM AS INTENDED FOR THE APPLICATION. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE CASE TOGETHER WITH THE RESULTS OF THE TECHNICAL INVESTIGATION, WERE SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATIONS: "WE ARE TOLD THAT THE COMPONENTS FROM A GALAXY STERILE LOWER LIMB KIT 99-93502 WERE APPLIED TO A PATIENT. LATER THAT DAY IT WAS FOUND THAT A COMPONENT WAS LOOSE. THE REPORT FORM SAYS THAT THE BONE POSITION WAS LOST, BUT DOES NOT CONFIRM THIS IN DIRECT QUESTIONS. WE DO NOT KNOW HOW THE SITUATION WAS DEALT WITH OR THE CURRENT CONDITION OF THE PATIENT. WE MUST ASSUME THAT THE BONE HAD TO BE REMANIPULATED ALTHOUGH THE FORM STATES THAT NO ADDITIONAL SURGERY OR MEDICAL INTERVENTION WAS REQUIRED. IT SEEMS THAT THIS WAS TEMPORARY FIXATION SO THE EXACT POSITION WAS NOT CRITICAL. THE SURGEON TIGHTENED THE LOOSE JOINT AND THE PATIENT LATER RECEIVED DEFINITIVE TREATMENT AS PLANNED. HOWEVER, HE HAD TO INTERVENE TO TIGHTEN THE LOOSE JOINT, AND IT IS POSSIBLE THAT THE PATIENT MAY HAVE COME TO HARM IF HE HAD NOT DONE THAT. ALL THE COMPONENTS CONCERNED WITH THIS EVENT HAVE BEEN CHECKED CAREFULLY AND ALL ARE FOUND TO BE FUNCTIONING NORMALLY AND WITHIN SPECIFICATION. THE ONLY SOLUTION, THEREFORE, IS AS SUGGESTED THAT THERE WAS SOMETHING SPECIFIC IN THIS APPLICATION THAT LED TO THE LOOSENING. IT IS NOT POSSIBLE TO SAY EXACTLY WHAT". CONCLUSION: THE RESULTS OF THE TECHNICAL EVALUATION EVIDENCED THAT THE RETURNED DEVICES, WHICH BELONGED TO THE STERILE KIT CODE 99-93503US BATCH B1476140, ARE CONFORMING TO ORTHOFIX SPECIFICATION. IT WAS NOT POSSIBLE TO REPLICATE THE FAILURE NOTIFIED. A COMPLETE MEDICAL EVALUATION WAS NOT POSSIBLE AS NO INFORMATION ABOUT THE MEDICAL PROCEDURE, DIAGNOSIS, X-RAYS AND PICTURE OF THE FRAME REALIZED HAVE BEEN MADE AVAILABLE. THE ANALYSIS OF THE HISTORICAL DATA EVIDENCED THAT NO OTHER SIMILAR NOTIFICATIONS HAVE BEEN RECEIVED ON DEVICES BELONGING TO THE SAME LOT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 0

    THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - PRODUCT CODE: 99-93502US (TIBIA FEMUR DIAPHYSEAL STERILE KIT) - BATCH NUMBER: B1384578 - QUANTITY: 1 - DATE OF INITIAL SURGERY: (B)(6) 2021. - BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA/ANKLE. - SURGERY DESCRIPTION: FRACTURE TREATMENT. - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: "AT TIME OF APPLICATION OF THE GALAXY PRODUCT, CODE 99-93502US, ALL PRODUCT WAS TIGHT. LATER IN THE DAY, THE DEVICE (CLAMPS), LOOSE AND LOST REDUCTION". THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. - THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. - THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE. - AN ADDITIONAL SURGERY WAS NOT REQUIRED. - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. - COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. - COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. - PRODUCT IS AVAILABLE FOR RETURN. ON (B)(6), 2021, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL DETAILS FROM THE SALES REPRESENTATIVE: - DATE OF THE INITIAL SURGERY: (B)(6), 2021. - PATIENT INFORMATION: BT, 40 YEARS, MALE, (B)(6) 1980. - AFTER SURGERY WAS COMPLETED, LATER THAT EVENING THE EXFIX WAS LOOSE. - IT SEEMS TO US THAT THE ISSUE MIGHT BE THE CLAMP OVER ANY OTHER OPTION (WRONG PIN SIZE OR WRONG BAR SIZE). ON (B)(6), 2021, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL DETAILS FROM THE SURGEON: - AFTER SURGERY WAS COMPLETED, LATER IN RECOVERY, LOOSENING OCCURRED. SURGEON WENT IN AND RETIGHTENED. - YES, LOSS OF REDUCTION OCCURRED. - XRAYS NOT AVAILABLE. - PATIENT CURRENT STATE OF HEALTH: "EXFIX WAS TEMPORARY FIXATION, SO CURRENTLY FRACTURE FIXATION WAS COMPLETED AND DOING WELL." MANUFACTURER REFERENCE NUMBER: 2021028. DISTRIBUTOR REFERENCE NUMBER: 286444.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE STERILE KIT CODE 99-93502US BATCH B1384578 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2019, WAS COMPRISED OF (B)(4) KITS. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION: THE DEVICE INVOLVED IN THIS EVENT HAS NOT YET BEEN RECEIVED BY ORTHOFIX SRL. ORTHOFIX SRL IS STRICTLY IN CONTACT WITH THE LOCAL DISTRIBUTOR TO HAVE THE DEVICE CONCERNED. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICE BECOMES AVAILABLE. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. A PRELIMINARY MEDICAL EVALUATION WAS PERFORMED AND WILL BE FINALIZED ONCE THE RESULTS OF THE INVESTIGATION ARE AVAILABLE. AS SOON AS THE RESULTS OF THE INVESTIGATION ARE AVAILABLE, ORTHOFIX SRL WILL PROVIDE A FOLLOW UP REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 1

    THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 99-93502US (TIBIA FEMUR DIAPHYSEAL STERILE KIT). BATCH NUMBER: B1384578. QUANTITY: 1. DATE OF INITIAL SURGERY: (B)(6) 2021. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA/ANKLE. SURGERY DESCRIPTION: FRACTURE TREATMENT. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "AT TIME OF APPLICATION OF THE GALAXY PRODUCT, CODE 99-93502US, ALL PRODUCT WAS TIGHT. LATER IN THE DAY, THE DEVICE (CLAMPS), LOOSE AND LOST REDUCTION". THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. PRODUCT IS AVAILABLE FOR RETURN. ON FEBRUARY 17, 2021, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL DETAILS FROM THE SALES REPRESENTATIVE: DATE OF THE INITIAL SURGERY: (B)(6) 2021. PATIENT INFORMATION: BT, (B)(6) YEARS, MALE, (B)(6). AFTER SURGERY WAS COMPLETED, LATER THAT EVENING THE EXFIX WAS LOOSE. IT SEEMS TO US THAT THE ISSUE MIGHT BE THE CLAMP OVER ANY OTHER OPTION (WRONG PIN SIZE OR WRONG BAR SIZE). ON FEBRUARY 19, 2021, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL DETAILS FROM THE SURGEON: AFTER SURGERY WAS COMPLETED, LATER IN RECOVERY, LOOSENING OCCURRED. SURGEON WENT IN AND RETIGHTENED. YES, LOSS OF REDUCTION OCCURRED. XRAYS NOT AVAILABLE. PATIENT CURRENT STATE OF HEALTH: "EXFIX WAS TEMPORARY FIXATION, SO CURRENTLY FRACTURE FIXATION WAS COMPLETED AND DOING WELL". MANUFACTURER REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287824 ANKLE TRANSFIX PIN STERILE KIT ANKLE TRANSFIX PIN STERILE KIT KTT ORTHOFIX SRL 99-93503US B1476140 18054242511298

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention