BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLOTTED MALLET ADAPTOR

    MDR report key: 9754769 · Received February 26, 2020

    Report

    Report Number
    9680825-2020-00019
    Event Type
    Injury
    Date Received
    February 26, 2020
    Date of Event
    January 27, 2020
    Report Date
    February 25, 2020
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HSB
    PMA / PMN Number
    K141571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE COMPONENT CODE 177071 LOT AC2002 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2016 WAS COMPRISED OF (B)(4). ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE COMPONENT CODE 177110 LOT 120364 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2017 WAS COMPRISED OF (B)(4). ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE COMPONENT CODE 177385 LOT AC2003 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2016 WAS COMPRISED OF (B)(4). ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. TECHNICAL EVALUATION: THE RETURNED DEVICES, RECEIVED ON 4TH FEBRUARY 2020 WERE EXAMINED BY ORTHOFIX (B)(4) QUALITY ENGINEERING DEPARTMENT. THE DEVICES WERE SUBJECTED TO VISUAL AND FUNCTIONAL CHECK AS PER ORTHOFIX (B)(4) SPECIFICATION. THE VISUAL CHECK CONFIRMED THAT THE NAIL ATTACHMENT ROD CODE 177110 AND THE SLOTTED MALLET ADAPTOR CODE 177385 ARE STUCK TOGETHER. THE IMPACTOR CODE 177071 IS BENT. THE NAIL ATTACHMENT ROD CODE 177110 AND THE SLOTTED MALLET ADAPTOR CODE 177385 ARE STUCK TOGETHER AND IT WAS NOT POSSIBLE TO SEPARATE THEM. THE IMPACTOR CODE 177071 IS HEAVILY DAMAGED. DUE TO THESE DAMAGES, THE DIMENSIONAL AND FUNCTIONAL CHECK CANNOT BE PERFORMED. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE EVENT WITH THE RESULTS OF THE TECHNICAL EVALUATION HAVE BEEN SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATIONS PERFORMED. (B)(6) 2020. THERE SEEM TO BE SEPARATE COMPLAINTS HERE: 1. "THE THREAD OF THE SLOTTED HAMMER ADAPTER HAS BEEN COLD WELDED TO THE THREAD OF THE NAIL ATTACHMENT. IT HAPPENED WHEN THE NAIL WAS INSERTED". 2. "TALUS SCREW COULD NOT BE LOCKED AND THEREFORE NO INTERNAL COMPRESSION WAS GENERATED". THE INSTRUMENTS INVOLVED ARE SLOTTED HAMMER ADAPTOR 177385, IMPACTOR 177071, AND NAIL ATTACHMENT ROD 177110. IT SEEMS THAT THE SLOTTED HAMMER ADAPTOR BECAME JAMMED INSIDE THE NAIL ATTACHMENT ROD, AND THEY HAD TO BE REMOVED AS ONE PIECE. BECAUSE OF THIS, IT WAS NOT POSSIBLE TO ACCESS THE MECHANISM TO LOCK THE TALAR SCREW OR TO COMPRESS THE NAIL. THEREFORE, THE SECOND PROBLEM IS SECONDARY TO THE FIRST. I CANNOT BEGIN TO UNDERSTAND WHY THERE WAS AN ALLEGED DELAY OF 1.5 HOURS. HOWEVER, THE PATIENT DID HAVE A SLIGHT PROBLEM BECAUSE IT WAS NOT POSSIBLE TO COMPLETE THE OPERATION AS ORIGINALLY PLANNED (AS FAR AS WE CAN TELL). HOWEVER, THE REPORTING OF THIS INCIDENT IS INCOMPLETE AND WE DO NOT KNOW THE PATIENT'S CURRENT CONDITION. (B)(4) 2020 WITH THE OUTCOME OF THE TECHNICAL ANALYSISIN THIS CASE A SLOTTED HAMMER ADAPTOR HAS BECOME LOCKED TO THE NAIL ATTACHMENT ROD OF AN AHN SET. IN MY EXPERIENCE, IF A SCREW IS INSERTED INCORRECTLY INTO A THREADED HOLE, THE THREADS WILL BE CROSSED AND AS A RESULT, THE SCREW IS ALWAYS AT A SLIGHT ANGLE TO THE THREAD. THIS IS WHY MANY MORE SCREWS ARE NOT INSERTED INCORRECTLY: IF THE THREADS ARE CROSSED, THE SCREW JAMS EARLY ON AND IT IS OBVIOUS BECAUSE IT IS ANGLED. THE SCREW IS WITHDRAWN AND REINSERTED AND ALL IS WELL. FINAL COMMENTS: THE RESULTS OF THE TECHNICAL EVALUATION CONCLUDED THAT THE RETURNED DEVICES WERE ORIGINALLY CONFORMING TO SPECIFICATION. IT IS POSSIBLE TO ASSUME THAT THE ADAPTOR HAS BEEN INSERTED INCORRECTLY IN THE NAIL ATTACHMENT ROD CAUSING THE CROSS THREADING BETWEEN THE COMPONENTS. DUE TO THIS FACT, IT WAS NOT POSSIBLE TO SEPARATE THE TWO COMPONENTS. THE BENDING OF THE IMPACTOR LEAD TO ASSUME THAT THIS DEVICE WAS USED AS LEVER, TRYING TO SEPARATE THE JAMMED COMPONENTS. THE FAILURE OCCURRED COULD BE MAINLY ATTRIBUTABLE TO THE CONDITIONS OF USE OF THE DEVICES. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE KINDLY REFER ALSO TO MFR REPORT NUMBER 9680825-2020-00017 AND 9680825-2020-00018. (B)(4).

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON'S NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2020. BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT ANKLE. SURGERY DESCRIPTION: N/A PATIENT'S INFORMATION: MALE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: THE THREAD OF THE SLOTTED HAMMER ADAPTER HAS BEEN COLD WELDED TO THE THREAD OF THE NAIL ATTACHMENT [ROD]. IT HAPPENED WHEN THE NAIL WAS INSERTED. TALUS SCREW COULD NOT BE LOCKED AND THEREFORE NO INTERNAL COMPRESSION WAS GENERATED. THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT. - THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. - THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE: TOTAL DELAY: APPROX. 1,5 HOURS. - AN ADDITIONAL SURGERY WAS NOT REQUIRED. - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. - COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE. - COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. - PATIENT CURRENT HEALTH CONDITIONS: N/A. FURTHER INFORMATION RECEIVED FROM THE LOCAL DISTRIBUTOR ON 12TH FEBRUARY 2020: -THE SURGERY DELAY WAS DUE TO THE SLOTTED HAMMER ADAPTOR JAMMED INSIDE THE NAIL ATTACHMENT ROD. -PATIENT'S CURRENT HEALTH CONDITION: ACTUALLY NOT KNOWN. PROBABLY ALL RIGHT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222147 SLOTTED MALLET ADAPTOR SLOTTED MALLET ADAPTOR HSB ORTHOFIX SRL 177385 AC2003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention