BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI-SCREW, STANDARD, SYS4.0, TX10, 32MM

    MDR report key: 7431976 · Received April 16, 2018

    Report

    Report Number
    0009613350-2018-00442
    Event Type
    Injury
    Date Received
    April 16, 2018
    Report Date
    September 14, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    PMA / PMN Number
    PK123347
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    - NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: SCREW MIGRATION. - DEVICE HISTORY RECORDS (DHR): THE DHR CHECK COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. NORMED MEDIZIN-TECHNIK GMBH IS A MEDICAL DEVICE COMPANY LOCATED IN TUTTLINGEN, GERMANY. NORMED MAINTAINS A QUALITY MANAGEMENT SYSTEM FOR DESIGN, MANUFACTURE AND FINAL INSPECTION OF THE RESPECTIVE DEVICES /DEVICE CATEGORIES IN ACCORDANCE WITH MDD ANNEX II AND WHICH FULFILS THE REQUIREMENTS OF ISO 13485:2012. DURING THE FINAL INSPECTION OF PRODUCTS AT NORMED, THE INSPECTION OF EACH BATCH WAS PERFORMED ACCORDING TO ESTABLISHED INSPECTION PLANS. ONLY IF ALL INSPECTION CHARACTERISTICS PASSED THE FINAL INSPECTION, THE RELEASE TO MARKET WAS GRANTED AND THE PRODUCTS WERE TRANSFERRED FROM THE QUARANTINE AREA TO THE WAREHOUSE. IF A NON-CONFORMITY WAS DETECTED THE AFFECTED PARTS WERE EITHER REWORKED, SCRAPPED OR ¿ IF POSSIBLE ¿ A CONCESSION WAS GRANTED. THEREFORE IT CAN BE CONCLUDED THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT DESCRIPTION (EVENT DETAILS, PER) - EVENT SUMMARY: IT WAS REPORTED THAT TWO NON-LOCKING SCREWS WERE REMOVED AS THEY WERE BACKING OUT OF AN ANKLE FIX PLUS PLATE, WHICH HAS BEEN IMPLANTED ON NOV 10, 2017. REVIEW OF RECEIVED DATA. - FIVE X-RAYS HAVE BEEN RECEIVED. THEY HAVE BEEN REVIEWED BY A RADIOLOGIST (DR. KUSH SINGH) FROM MEDICAL METRICS INC. - X-RAY DATED (B)(6) 2017 : LATERAL PLATE AND SCREW FIXATION OF THE HINDFOOT WITH FUSION OF THE TIBIA AND POSSIBLY AN OSTEOTOMY IN THE REGION OF THE TALUS WITH LIKELY FUSION OF THE CALCANEUS. BONY FRAGMENTATION NOTED LATERAL TO THE PLATE. DISTAL FIBULAR RESECTION. DIFFUSE SOFT TISSUE SWELLING BILATERALLY. SCATTERED METALLIC FRAGMENTS ARE SEEN WITHIN THE LATERAL SOFT TISSUES. - X-RAY DATED (B)(6) 2017 LATERAL PLATE AND SCREW FIXATIONWITH BONYFUSION OF THE HINDFOOT. PARTIAL WITHDRAWAL OF THE DISTAL MOST SCREW. OSTEOPENIA. DISTAL FIBULAR RESECTION WITH PUNCTATE METALLIC FOCI WITHIN THE LATERAL SOFT TISSUES. BONY FRAGMENTATION LATERALLY AT THE LEVEL OF THE ANKLE JOINT. -X-RAY DATED (B)(6) 2018 HINDFOOT FUSION WITH PARTIAL WITHDRAWAL OF THE DISTAL MOST SCREW. POSSIBLE JOINT SPACE SEEN AT THE TIBIOTALAR JOINT WITHOUT COMPLETE BONY FUSION OF THE HINDFOOT. DISTAL FIBULAR RESECTION. DIFFUSE BILATERAL MALLEOLAR SOFT TISSUE SWELLING WITH PUNCTATE HYPERDENSITIES ALONG THE LATERAL SOFT TISSUES. - X-RAY DATED (B)(6) 2018 LATERAL PLATE AND SCREW FIXATION OF THE HINDFOOT WITH FUSION OF THETIBIA,, TALUS AND LIKELY CALCANEUS. SEVERAL SCREWS APPEAR TO HAVE WITHDRAWN INCLUDING THE DISTAL SCREWS. BONY FUSION OF THE HINDFOOT IS LIKELY PRESENT. DISTAL FIBULAR RESECTION. DIFFUSE SOFT TISSUE SWELLING. - X-RAY DATED (B)(6) 2018 LATERAL PLATE AND SCREW FIXATION WITH FUSION OF THE HINDFOOT. WITHDRAWAL OF 2 OF THE DISTAL SCREWS. DISTAL FIBULAR RESECTION. BONY FRAGMENTATION LATERAL TO THE JOINT SPACE. MULTIPLE METALLIC FRAGMENTS ARE SEEN WITHIN THE LATERAL SOFT TISSUES. DIFFUSE SOFT TISSUE SWELLING. FURTHER IT IS FOUND THAT THE IMPLANTS ARE THE CORRECT SIZE FOR THE PATIENT ANATOMY. THE PLATE DOES NOT APPEAR TO BE BENT OR ALTERED, ALTHOUGH THERE IS SLIGHT BOWING OF THE PLATE WHICH IS THOUGHT TO BE RELATED TO EXPECTED POSTSURGICAL CHANGE AND RELATED TO FITTING THE PATIENT'S ANATOMYDURING SURGERY. THIS WOULD CORRELATE CLINICALLY. MOREOVER, THE PATIENT WAS FOUND TO BE OSTEOPENIC. DEVICES ANALYSIS. NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS; ACCORDING TO THE INFORMATION RECEIVED THE PRODUCT LOCATION IS UNKNOWN. REVIEW OF PRODUCT DOCUMENTATION. - SURGICAL TECHNIQUE: THE SURGICAL TECHNIQUE FOR ANKLE FIX SYSTEM 4.0 CONTAINS INFORMATION AND ILLUSTRATIONS ABOUT ALL THE STEPS NEEDED FOR THE IMPLANTATION OF AN ANKLE FIX PLATE. THE SURGICAL TECHNIQUE EXPLAINES THE INSERTION OF THE DISTAL SCREWS INSERTION. IT IS MENTIONED THAT IT IS RECOMMENDED TO ¿USE AS MANY SCREW HOLES AS POSSIBLE TO ENSURE STABLE FIXATION. " MOREOVER, THE DEPTH GAUGE SHOULD BE ADVANCED INTO THE PREDRILLED HOLES UNTIL IT PENETRATES THE OPPOSITE CORTEX TO DETERMINE THE CORRECT SCREW LENGTH. ROOT CAUSE ANALYSIS. ROOT CAUSE DETERMINATION USING RMW: - IMPLANT MIGRATION DUE TO MRI INTERACTS WITH TITANIUM IMPLANT COMPONENTS POSSIBLE, A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - PLATE BENDING DUE TO LACK OF ADEQUATE STRENGTH NOT POSSIBLE A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - REDUCED BIOMECHANICAL ANCHORAGE OR DISCONNECTION OF PLATES AND LOCKING SCREWS DUE TO LACK OF ADEQUATE DESIGN OF MATING COMPONENTS NOT POSSIBLE A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. MOREOVER, THE X-RAY REVIEW FOUND THAT THE PLATE IS NOT BENT EXTRAORDINARY. - INFLUENCE ON OSTEOSYNTHESIS, PROLONGED CONVALESCENCE DUE TO OVERSTRAINING OF IMPLANTS DUE TO HIGH ACTIVITY LEVEL POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. DESPITE THE FACT THAT THE ACTIVITY LEVEL O FHTE PATIENT HAS BEEN DESCRIBED AS LOW, IT REMAINS UNKNOWN WHETHER THE PATIENT HAS BEEN COMPLIANT. CONCLUSION SUMMARY. IT WAS REPORTED THAT TWO NON-LOCKING SCREWS WERE REMOVED AS THEY WERE BACKING OUT OF AN ANKLE FIX PLUS PLATE. THE MIGRATION OF THE SCREWS STARTED APPROXIMATELY ONE MONTHS AFTER IMPLANTATION. THE REVIEW OF THE X-RAY DETERMINED THAT THE PLATE DOES NOT APPEAR TO BE BENT OR ALTERED, ALTHOUGH THERE IS SLIGHT BOWING OF THE PLATE WHICH IS THOUGHT TO BE RELATED TO EXPECTED POSTSURGICAL CHANGE AND RELATED TO FITTING THE PATIENT'S ANATOMYDURING SURGERY. THIS WOULD CORRELATE CLINICALLY. MOREOVER, THE PATIENT WAS FOUND TO BE OSTEOPENIC, WHICH COULD HAVE CONTRIBUTED TO THE MIGRATION OF THE SCREW. ANOTHER CONTRIBUTING FACTOR MIGHT BE THE OBESITY OF THE PATIENT. THE POSTOPERATIVE INSTRUCTIONS GIVEN TO THE PATIENT REGARDING PARTIAL OR FULL WEIGHT BEARING ARE UNKNOWN AND IT IS ALSO UNKNOWN WHETHER THE PATIENT WAS COMPLIANT. HOWEVER, AN EXACT ROOT CAUSE FOR THE MIGRATION OF THE SCREWS COULD NOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER BIOMET CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM # 28.14.106, ITEM NAME: ANKLE FIX PLUS TI-PLATE, STANDARD, RIGHT, LOT# UNKNOWN; ITEM # 28.30.124, ITEM NAME: TI-SCREW, STANDARD, SYS4.0, TX10, 24MM , LOT# UNKNOWN. THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2018-00372 AND 0009613350-2018-00371. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. X-RAYS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED AN ANKLE PLATE AND THAT LATER ON TWO NON-LOCKING SCREWS WERE BACKING OUT OF THE PLATE. THE SCREWS WERE REMOVED IN PHYSICIAN OFFICE UNDER LOCAL ANESTHETIC. IT WAS FURTHER REPORTED THAT THE SURGEON BENT THE PLATE WHICH COULD HAVE DISRUPTED THE INTEGRITY OF THE LOCKING HOLE THREADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276259 TI-SCREW, STANDARD, SYS4.0, TX10, 32MM NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0 HRS ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R