BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDED GROWTH PLATE SYSTEM PLUS TI CANNULATED SCREW L32MM D4.5MM

    MDR report key: 16910131 · Received May 11, 2023

    Report

    Report Number
    9680825-2023-00017
    Event Type
    Malfunction
    Date Received
    May 11, 2023
    Date of Event
    March 23, 2023
    Report Date
    September 11, 2023
    Manufacturer
    ORTHOFIX SRL
    Product Code
    OBT
    PMA / PMN Number
    K172183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF HISTORICAL RECORDS. THE LOT NUMBER OF THE SCREW DEVICE CODE T80132 HAS NOT BEEN MADE AVAILABLE AND THEREFORE IT WAS NOT POSSIBLE TO PERFORM THE VERIFICATION OF THE HISTORICAL DATA. ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE SCREW EXTRACTOR DEVICE CODE DH0474CE LOT G007 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2017, WAS COMPRISED OF (B)(4) UNITS. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED REGARDING THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION. ORTHOFIX SRL QUALITY OPERATIONS DEPARTMENT RECEIVED AND EXAMINED A PORTION OF A BROKEN GUIDED GROWTH PLATE SYSTEM PLUS TI CANNULATED SCREW L32MM D4.5MM CODE T80132 BATCH UNKNOWN STUCK TOGETHER WITH A GUIDED GROWTH SCREW EXTRACTOR CODE DH0474CE BATCH G007. THE VISUAL CHECK EVIDENCED THAT THE SCREW IS WORN AND DAMAGED IN CORRESPONDENCE TO THE CRESTS AND THE HEAD. MOREOVER, THE GREEN ANODIZED LAYER WAS ALMOST COMPLETELY REMOVED. THE BREAKAGE OCCURRED AT THE MIDDLE OF THE SCREW LENGTH, I.E., AT THE FIFTH CREST WITH RESPECT TO SCREW HEAD. THE FAILURE MODE SUGGESTS A TORSIONAL OVERLOAD. THE LASER MARKING AT SCREW HEAD IS DAMAGED, MAKING THE LOT TRACEABILITY NOT POSSIBLE. ALSO THE SCREW EXTRACTOR, WHERE THE SCREW IS STUCK, EVIDENCED SIGNS OF USE. THE DEVICE WAS THEN SENT TO AN EXTERNAL LABORATORY FOR THE FAILURE ANALYSIS AND THE RAW MATERIAL CHECK. THE ANALYSIS PERFORMED EVIDENCED THAT THE SCREW TIP SHOWS SIGNS OF TEARING ALONG THE THREAD BASE WITH A STRONG MACROSCOPIC DEFORMATION, COHERENT WITH A TORSIONAL OVERLOAD. THE SEM ANALYSIS CONFIRMED A MICROSCOPIC STRUCTURE COHERENT WITH A TORSIONAL OVERLOAD. FROM LATERAL VIEW OF THE FRACTURE IT IS POSSIBLE TO SEE HOW THE MATERIAL YIELDED AT THE THREAD BASE, CAUSING IT TO "UNWIND". THE RESULTS OF THE RAW MATERIAL ANALYSIS CONFIRMED THAT THE ITEM IS IN CONFORMITY WITH ORTHOFIX SPECIFICATIONS. IT WAS NOT POSSIBLE TO PERFORM THE FUNCTIONAL CHECK AS SCREW AND EXTRACTOR ARE STUCK TOGETHER AND CANNOT BE SEPARATED. MEDICAL EVALUATION. THE INFORMATION MADE AVAILABLE ON THE EVENT, TOGETHER WITH THE RESULT OF THE TECHNICAL EVALUATION, WERE SENT TO OUR MEDICAL CONSULTANT. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATIONS PERFORMED: THIS PATIENT IS 11 AND HAD AN 8-PLATE INSERTED ABOUT 12 MONTHS AGO. SHE WAS GETTING SOME PAIN, SO THE IMPLANT WAS REMOVED (I ASSUME, THOUGHT THEY DON'T SAY). ONE OF THE SCREW HEADS TWISTED OFF WITH THE SCREW EXTRACTOR LEAVING A PORTION OF THREAD BEHIND. THERE IS NO MENTION OF RETAINED FRAGMENTS EXCEPT IN YOUR SUMMARY. I AM SURE THAT THE PATIENT WILL COME TO NO HARM, BUT WE SHOULD SEE AN X-RAY TO BE SURE THAT THE FRAGMENT IS NOT ENCROACHING ON THE EPIPHYSEAL PLATE. THIS TECHNICAL REPORT REFERS TO AN EIGHT-PLATE SCREW, T80132, CANNULATED SCREW D4.5 MM, L32 MM, WHICH BROKE ON REMOVAL. THE TECHNICAL REPORT SHOWS THAT THE SCREW MATERIAL WAS AS SPECIFIED, AND THAT IT BROKE BECAUSE OF A TORSIONAL LOAD. THE SCREW WOULD NOT START TO MOVE USING THE STANDARD SCREWDRIVER, SO THE SCREW EXTRACTOR WAS USED. THIS WORKED EXACTLY AS DESIGNED AND FORMED A FIRM BONE WITH THE SCREW HEAD. WHEN THE SCREW WAS EXTRACTED, THE BOND BETWEEN THE SCREW AND THE BONE MUST HAVE BEEN SO STRONG THAT THE DISTAL HALF OF THE SCREW BROKE OFF, RATHER THAN COME LOOSE. THE DISTAL FRAGMENT OF THE SCREW IS THEREFORE REMAINING INSIDE THE PATIENT. THIS IS A KNOWN RISK FOR SCREW EXTRACTIONS, BUT WE KNOW FROM PREVIOUS EXPERIENCE THAT THE RISK IS LOW. THE SCREW IS MADE OF TITANIUM AND THE RETAINED FRAGMENT IS BIOLOGICALLY INERT AND WILL CAUSE NO PROBLEMS FOR THE PATIENT. WE HAVE NOT SEEN AN X-RAY OF THE RETAINED FRAGMENT, AND WE ADVISED THAT THIS SHOULD BE DONE TO CONFIRM THAT THE FRAGMENT IS NOT NEXT TO A SENSITIVE STRUCTURE. I AGREE WITH THE TECHNICAL ANALYSIS CONCLUSION THAT THIS SCREW BROKE BECAUSE OF TORSIONAL OVERLOAD. FINAL COMMENTS. THE RESULTS OF THE TECHNICAL ANALYSIS CONFIRMED THAT THE PORTION OF THE SCREW RETURNED IS BROKEN AND DAMAGED IN THE THREADS AND HEAD. THE EVIDENCE COLLECTED LEAD TO ASSUME THAT THE FAILURE OCCURRED IS RELATED TO A TORSIONAL OVERLOAD APPLIED DURING SCREW REMOVAL. MATERIAL COMPOSITION, HARNESS AND MICROSTRUCTURE ARE COHERENT WITH SPECIFICATIONS. NO DEFECTS WERE DETECTED. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET. (B)(6)HOSPITAL REPORT REFERENCE, (B)(4) PROVIDED THROUGH FDA'S MEDSUN PROGRAM.

    Additional Manufacturer Narrative · 0

    ANALYSIS OF HISTORICAL RECORDS: THE DEVICE INVOLVED IN THIS EVENT HAS NOT YET BEEN RECEIVED BY ORTHOFIX SRL. UNFORTUNATELY ALSO THE LOT NUMBER HAS NOT BEEN MADE AVAILABLE AND THEREFORE IT WAS NOT POSSIBLE TO PERFORM THE VERIFICATION OF THE HISTORICAL DATA. TECHNICAL EVALUATION: THE DEVICE INVOLVED IN THIS EVENT HAS NOT YET BEEN RECEIVED BY ORTHOFIX SRL. 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. -(B)(6) REPORT REFERENCE, (B)(4) PROVIDED THROUGH FDA'S MEDSUN PROGRAM.

    Description of Event or Problem · 0

    THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON'S NAME: (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2023. BODY PART TO WHICH DEVICE WAS APPLIED: LEFT KNEE. SURGERY DESCRIPTION: CORRECTION, REMOVAL OF IMPLANT. PATIENT INFORMATION: 11 YEAR-OLD, FEMALE, 59 KG., PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. EVENT DESCRIPTION: THE PROXIMAL SCREW WOULD NOT COME OUT AND STARTED STRIPPING. THE STRIPPED SCREW EXTRACTOR WAS USED. THE SCREW BROKE AT THE THREADS. THE HEAD AND PORTION OF SCREW WAS REMOVED. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: UN-RETRIEVED DEVICE FRAGMENTS. 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. PATIENT CURRENT HEALTH CONDITION: NA. ON 8 MAY 2023, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE LOCAL DISTRIBUTOR: DR. (B)(6) PERFORMED A REVISION SURGERY ON (B)(6) 2023 TO REMOVE TWO 32 X 4.5MM SCREWS DUE TO PATIENT EXPERIENCING PAIN. THE EXTRACTOR STRIPPED IN THE HEAD OF THE SCREW AND BROKE THE SCREW. THE TIP OF THE SCREW REMAINS IMPLANTED. THE INITIAL IMPLANT DATE WAS (B)(6) 2022. FURTHER INFORMATION RECEIVED FROM THE LOCAL DISTRIBUTOR: IT WAS NOT POSSIBLE TO GET THE X-RAY IMAGES. MANUFACTURER REFERENCE NUMBER: (B)(4). DISTRIBUTOR REFERENCE NUMBER: (B)(4). (B)(4) HOSPITAL REPORT REFERENCE, (B)(4) PROVIDED THROUGH FDA'S MEDSUN PROGRAM.

    Description of Event or Problem · 0

    THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: (B)(6). - SURGEON'S NAME: (B)(6). - DATE OF INITIAL SURGERY: (B)(6) 2023. - BODY PART TO WHICH DEVICE WAS APPLIED: LEFT KNEE. - SURGERY DESCRIPTION: CORRECTION, REMOVAL OF IMPLANT. - PATIENT INFORMATION: 11 YEAR-OLD, FEMALE, 59 KG. - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. - EVENT DESCRIPTION: THE PROXIMAL SCREW WOULD NOT COME OUT AND STARTED STRIPPING. THE STRIPPED SCREW EXTRACTOR WAS USED. THE SCREW BROKE AT THE THREADS. THE HEAD AND PORTION OF SCREW WAS REMOVED. THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: UN-RETRIEVED DEVICE FRAGMENTS. - 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. - PATIENT CURRENT HEALTH CONDITION: NA. ON 8 MAY 2023, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE LOCAL DISTRIBUTOR: (B)(6) PERFORMED A REVISION SURGERY ON (B)(6) 2023 TO REMOVE TWO 32 X 4.5MM SCREWS DUE TO PATIENT EXPERIENCING PAIN. THE EXTRACTOR STRIPPED IN THE HEAD OF THE SCREW AND BROKE THE SCREW. THE TIP OF THE SCREW REMAINS IMPLANTED. THE INITIAL IMPLANT DATE WAS (B)(6) 2022. MANUFACTURER REFERENCE NUMBER: (B)(4). DISTRIBUTOR REFERENCE NUMBER: (B)(4). (B)(6) REPORT REFERENCE, (B)(4) PROVIDED THROUGH FDA'S MEDSUN PROGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2184486 GUIDED GROWTH PLATE SYSTEM PLUS TI CANNULATED SCREW L32MM D4.5MM GUIDED GROWTH PLATE SYSTEM PLUS TI CANNULATED SCREW L32MM D4.5MM OBT ORTHOFIX SRL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Female Required Intervention