BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG STRUT TL-HEX - 158MM-318MM

    MDR report key: 5969288 · Received September 22, 2016

    Report

    Report Number
    9680825-2016-00080
    Event Type
    Injury
    Date Received
    September 22, 2016
    Date of Event
    June 16, 2016
    Report Date
    November 22, 2016
    Manufacturer
    ORTHOFIX SRL
    Product Code
    KTT
    PMA / PMN Number
    K152171
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    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 50-10400 LOT V1418275 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2016, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. TECHNICAL EVALUATION THE FOUR RETURNED DEVICES, RECEIVED ON SEPTEMBER 22 (2 X LONG STRUT TL-HEX - 158MM-318MM CODE 50-10400 LOT V1418275; 1 X TRUE LOK PLUS MEDIUM QUICK ADJUST STRUT CODE 50-10180 LOT V1417371) AND ON OCTOBER 17 (1 X MEDIUM STRUT TL-HEX - 114MM-184MM CODE 50-10300 LOT V1418253), 2016, WERE EXAMINED BY ORTHOFIX (B)(4) QUALITY ENGINEERING AREA. THE DEVICES WERE SUBJECTED TO VISUAL AND FUNCTIONAL CHECK AS PER ORTHOFIX (B)(4) DESIGN SPECIFICATIONS. ·ITEMS 50-10400 AND 50-10300: THE VISUAL CHECK DID NOT EVIDENCE ANY ANOMALIES. HOWEVER, THE DEVICES ARE PARTIALLY DISCOLOURED, PROBABLY DUE TO REPROCESSING CYCLES. THE FUNCTIONAL CHECK PERFORMED ON ITEMS 50-10400 AND 50-10300 CONFIRMED THAT THEY STILL FUNCTION PROPERLY. THE BOLT THAT KEEPS THE ACUTE ADJUSTMENT WASHER COULD BE EASILY UNSCREWED USING A 10MM HEX WRENCH AND THEN THE INNER TUBE COULD SLIDE CORRECTLY INSIDE THE OUTER TUBE. ·ITEM 50-10180 THE VISUAL CHECK EVIDENCED THAT THE SPIRAL RETAINING RING WAS MISSING. THE DEVICE WAS DISASSEMBLED DUE TO THE COMING OUT OF THE RETAINING RING. THE DIMENSIONAL CHECK EVIDENCED THAT THE RADIUS OF THE RETAINING RING GROOVE IS NOT CONFORMING TO ORTHOFIX (B)(4) SPECIFICATIONS. IT WAS NOT POSSIBLE TO PERFORM A COMPLETE FUNCTIONAL TEST OF ITEM 50-10180 AS THE SPIRAL RETAINING RING PARTS ARE MISSING. -ITEMS 50-10400 AND 50-10300 ORTHOFIX FAILURE ANALYSIS CONCLUDED THAT THE DEVICES WERE ORIGINALLY CONFORMING TO SPECIFICATIONS AND THAT THEY STILL PERFORM PROPERLY. -ITEM 50-10180 ORTHOFIX FAILURE ANALYSIS CONCLUDED THAT THE GROOVE WIDTH OF THE DEVICE IS OUTSIDE DRAWING SPECIFICATION. IN ADDITION, SANDBLASTING PERFORMED WAS APPLIED ALSO ON DETAILS THAT SHOULD BE MASKED. THE PRODUCT FAILURE COULD BE MAINLY ATTRIBUTABLE TO A COMBINATION OF THE MISSING RETAINING RINGS WITH THE NON-CONFORMING GROOVE DIMENSIONS. 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 PERFORMED. 18 SEPTEMBER 2016: "WE ARE NOT PROVIDED WITH ENOUGH INFORMATION TO KNOW WHETHER ANY DELAY THAT OCCURRED WAS SIGNIFICANT OR NOT. THE REPORT SUGGESTS THAT THE DEVICES WERE FOUND TO BE FAULTY BEFORE THE OPERATION BEGAN, AND SHOULD HAVE BEEN CHECKED PRIOR TO PACKAGING FOR STERILISATION." ON 04 NOVEMBER 2016 BASED ON THE RESULTS OF THE TECHNICAL ANALYSIS: "IT SEEMS THAT 2 OF THE STRUTS WERE CONFORMING TO SPECIFICATIONS, AND ONE HAS A VERY SMALL NON CONFORMITY IN DIMENSIONS THAT MIGHT BE RELEVANT TO THEIR COMPLAINT. IT IS NOT COMPLETELY CLEAR TO ME EXACTLY WHY THE STRUTS ARE NOT CONSIDERED TO BE FUNCTIONAL; FROM THE VIDEO'S IT SEEMS THAT THE SLIDING MOVEMENT IS GETTING BRIEFLY STUCK BUT THEN MOVED ON TO THE FULL EXTENT EXPECTED. SO, THE MOVEMENT IS NOT SMOOTH. HOWEVER, IN THE TECHNICAL ANALYSIS IT WAS FOUND THAT TWO OF THE STRUTS HAD COMPLETELY NORMAL FUNCTIONALITY, AND THE QUICK ADJUST STRUT - 50-10180 - HAD SOME PROFILE ISSUES WHICH MIGHT HAVE BEEN RELEVANT (I.E. MIGHT HAVE CAUSED THE SLIDING TO NOT BE SMOOTH). IT SEEMS THAT THE UNITS 50-10400 AND 50-10300 PERFORMED NORMALLY WHEN CHECKED AND HAD NO FAULTS IN DIMENSIONS. I DO NOT THINK THAT WE HAVE ENOUGH INFORMATION IN THIS CASE TO MAKE ANY SENSE OF EXACTLY WHAT OPERATION WAS PLANNED AND HOW THESE PERCEIVED NON CONFORMITIES MIGHT HAVE AFFECTED ITS PROGRESS." FINAL COMMENTS: -ITEMS 50-10400 AND 50-10300 ORTHOFIX FAILURE ANALYSIS CONCLUDED THAT THE DEVICES WERE ORIGINALLY CONFORMING TO SPECIFICATIONS AND THAT THEY STILL PERFORM PROPERLY. -ITEM 50-10180 ORTHOFIX FAILURE ANALYSIS CONCLUDED THAT THE GROOVE WIDTH OF THE DEVICE IS OUTSIDE DRAWING SPECIFICATION. THE PRODUCT FAILURE COULD BE MAINLY ATTRIBUTABLE TO A COMBINATION OF THE MISSING RETAINING RINGS WITH THE NON-CONFORMING GROOVE DIMENSIONS. THE RESULTS OF THE VERIFICATION OF THE RISK ANALYSIS DO NOT EVIDENCE THE NECESSITY TO IMPLEMENT ANY MEANS OF RISK MITIGATION. A COMPLETE MEDICAL EVALUATION OF THE CASE WAS NOT PERFORMED AS SOME INFORMATION ABOUT THE MEDICAL PROCEDURE WAS NOT MADE AVAILABLE, I.E. WHICH WAS THE STRUT THAT CAUSED THE PROLONGATION OF SURGERY TIME AND WHICH DEFECTED STRUTS WERE OBSERVED DURING PRE-USE INSPECTION, SEQUENCE OF EVENTS, WHAT WAS THE PLANNED FRAME TO BE USED, AMOUNT OF EXTRA ANAESTHESIA REQUIRED, POST-OP X-RAY IMAGES, COPY OF OPERATIVE REPORTS. ORTHOFIX (B)(4) HISTORICAL RECORDS SHOWS THAT NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THESE SPECIFIC DEVICE LOTS. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00079 FOLLOW UP1, 9680825-2016-00081 FOLLOW UP 1 AND 9680825-2016-00091 FOLLOW UP 1.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 50-10400, LOT V1418275 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2016, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. TECHNICAL EVALUATION THE DEVICES INVOLVED IN THIS EVENT HAVE NOT YET BEEN RECEIVED BY ORTHOFIX (B)(4). ORTHOFIX (B)(4) IS STRICTLY IN CONTACT WITH THE LOCAL DISTRIBUTOR TO HAVE THE DEVICES CONCERNED. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICES BECOME AVAILABLE MEDICAL EVALUATION THE INFORMATION 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 TECHNICAL EVALUATION ARE AVAILABLE. AS SOON AS THE RESULTS OF THE TECHNICAL INVESTIGATION ARE AVAILABLE, ORTHOFIX (B)(4) WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00079 AND 9680825-2016-00081. (B)(4).

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DEVICE CODE: 50-10400 (LONG STRUT TL-HEX - 158MM-318MM); LOT NUMBER: V1418275; QUANTITY: 2; DEVICE CODE: 50-10180 (TRUE LOK PLUS MEDIUM QUICK ADJUST STRUT); LOT NUMBER: V1417371; QUANTITY: 1; DEVICE CODE: 50-10300 (MEDIUM STRUT TL-HEX - 114MM-184MM); LOT NUMBER: V1418253; QUANTITY: 1; HOSPITAL NAME: (B)(6); SURGEON'S NAME: DR. (B)(6); DATE OF INITIAL SURGERY: (B)(6) 2016, BODY PART TO WHICH DEVICE WAS APPLIED: LOWER LIMB (TIBIA); SURGERY DESCRIPTION: CORRECTION; PATIENT'S INFORMATION: (B)(6); PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; EVENT DESCRIPTION: STRUT NOT WORKING PROPERLY (ATTACHED VIA EMAIL VIDEOS SHOWING THE PROBLEM). THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT; THE SURGERY WAS NOT COMPLETED WITH USED DEVICE; A REPLACEMENT WAS IMMEDIATELY AVAILABLE TO COMPLETE SURGERY; THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE -TOTAL DELAY; AN ADDITIONAL SURGERY WAS NOT REQUIRED; A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED; COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE; COPIES OF X-RAY IMAGES ARE AVAILABLE (PRE-OP ONLY); INFORMATION ABOUT PATIENT CURRENT HEALTH CONDITION: PATIENT IS ONGOING ON EXPECTED PLAN. NOT AFFECTED WITH THE DEFECTIVE DEVICES. FURTHER INFORMATION RECEIVED FROM THE DISTRIBUTOR ON SEPTEMBER 20, 2016: -THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE -TOTAL DELAY: IT MEANS THAT IT TAKES LONGER ANESTHESIA TIME. EXTRA ANESTHESIA REQUIRED. OPERATION DONE AT THE SAME DAY. -PROBLEM OBSERVED DURING: INTRA-OP. -PATIENT'S CURRENT HEALTH CONDITION: GOING WELL. -STRUTS COLLECTED FROM HOSPITAL HAS REFERENCE CODES AS FOLLOWING: A) (50-10400) 2 PCS; B) (50-10180) 1 PC. -THERE HAS BEEN PROLONGATION OF OPERATION TIME: AS AFTER FIXATION ,SURGEON NOTICED THAT ONE STRUT NOT WORKING PROPERLY AND HE HAD TO CHANGE IT AND REASSEMBLE WHILE OTHER DEFECTED STRUTS OBSERVED DURING PRE-USE INSPECTION. -ATTACHED: PRE-OP X-RAY. PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2016-00079 FOLLOW UP 1, 9680825-2016-00081 FOLLOW UP 1 AND 9680825-2016-00091 FOLLOW UP 1. MANUFACTURER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DEVICE CODE: 50-10400 (LONG STRUT TL-HEX - 158MM-318MM); LOT NUMBER: V1418275; QUANTITY: 2; DEVICE CODE: 50-10180 (TRUE LOK PLUS MEDIUM QUICK ADJUST STRUT); LOT NUMBER: V1417371; QUANTITY: 1; HOSPITAL NAME: (B)(6); SURGEON'S NAME: DR. (B)(6); DATE OF INITIAL SURGERY: (B)(6) 2016. BODY PART TO WHICH DEVICE WAS APPLIED: LOWER LIMB (TIBIA); SURGERY DESCRIPTION: CORRECTION; PATIENT'S INFORMATION: (B)(6) YEARS OLD, FEMALE, WEIGHT (B)(6); HEIGHT (B)(6); PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; EVENT DESCRIPTION: STRUT NOT WORKING PROPERLY. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT; THE SURGERY WAS NOT COMPLETED WITH USED DEVICE; A REPLACEMENT WAS IMMEDIATELY AVAILABLE TO COMPLETE SURGERY; THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE -TOTAL DELAY. AN ADDITIONAL SURGERY WAS NOT REQUIRED; A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED; COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE; COPIES OF X-RAY IMAGES ARE AVAILABLE (PRE-OP ONLY); INFORMATION ABOUT PATIENT CURRENT HEALTH CONDITION: PATIENT IS ONGOING ON EXPECTED PLAN. NOT AFFECTED WITH THE DEFECTIVE DEVICES. FURTHER INFORMATION RECEIVED FROM THE DISTRIBUTOR ON (B)(6) 2016: THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE -TOTAL DELAY: IT MEANS THAT IT TAKES LONGER ANESTHESIA TIME. EXTRA ANESTHESIA REQUIRED. OPERATION DONE AT THE SAME DAY. PROBLEM OBSERVED DURING: INTRA-OP. PATIENT'S CURRENT HEALTH CONDITION: GOING WELL. (B)(4). THERE HAS BEEN PROLONGATION OF OPERATION TIME: AS AFTER FIXATION ,SURGEON NOTICED THAT ONE STRUT NOT WORKING PROPERLY AND HE HAD TO CHANGE IT AND REASSEMBLE WHILE OTHER DEFECTED STRUTS OBSERVED DURING PRE-USE INSPECTION. PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2016-00079 AND 9680825-2016-00081. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620544 LONG STRUT TL-HEX - 158MM-318MM LONG STRUT TL-HEX - 158MM-318MM KTT ORTHOFIX SRL 50-10400 V1418275

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention