BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M7 CONICAL MALLET ADAPTOR

    MDR report key: 11312430 · Received February 11, 2021

    Report

    Report Number
    9680825-2021-00011
    Event Type
    Injury
    Date Received
    February 11, 2021
    Date of Event
    December 23, 2020
    Report Date
    March 17, 2021
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HSB
    PMA / PMN Number
    K172699
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 183336 BATCH G180555 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2019, WAS COMPRISED OF 23 DEVICES. 19 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 CODE. TECHNICAL EVALUATION THE RETURNED DEVICE, RECEIVED ON FEBRUARY 8, 2021, WAS EXAMINED BY ORTHOFIX SRL QUALITY ENGINEERING DEPARTMENT. THE DEVICE WAS SUBJECTED TO VISUAL, DIMENSIONAL AND FUNCTIONAL CHECK AS PER ORTHOFIX SPECIFICATION. THE VISUAL CHECK EVIDENCED THAT THE THREADED PART OF THE CONICAL MALLET ADAPTOR IS DAMAGED. THE DIMENSIONAL CHECK, PERFORMED WHERE POSSIBLE, DID NOT EVIDENCE ANY ANOMALIES. THE FUNCTIONAL CHECK WAS PERFORMED USING A NAIL TAKEN FROM THE STOCK. DESPITE THE DAMAGING SIGNS DETECTED ON THE THREADED PART, THE RETURNED DEVICE WAS FOUND TO BE IN CONFORMANCE TO THE SPECIFICATION. IT COULD FUNCTION AS EXPECTED. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE EVENT TOGETHER WITH THE RESULTS OF THE TECHNICAL EVALUATION WERE SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATIONS PERFORMED. "I UNDERSTAND THAT IN THIS CASE THE PATIENT, A 14 YEAR OLD GIRL, HAD AN AGILE NAIL IMPLANTED IN A FEMUR IN THE PAST, WE KNOW NOT WHEN. THERE WAS AN OPERATION ON (B)(6) 2020 TO ATTEMPT TO REMOVE THE NAIL. THE INSTRUMENT COULD NOT BE ENGAGED IN THE NAIL AND THE ATTEMPTED REMOVAL WAS ABANDONED AFTER 2.5 HOURS. THE AGILE NAIL M7 CONICAL MALLET ADAPTOR WAS USED TO TRY TO REMOVE THE NAIL BUT THEY COULD NOT ENGAGE IT AND AFTER 2.5 HOURS THE OPERATION WAS ABANDONED. X-RAYS WILL BE AVAILABLE, WE ARE TOLD. CLEARLY THIS MUST BE CONSIDERED A SERIOUS INJURY BECAUSE THE OPERATION FAILED AND FURTHER SURGERY IS REQUIRED. IT DEMONSTRATES ONLY TOO CLEARLY HOW SOMETIMES IT IS MORE DIFFICULT TO REMOVE AN IMPLANT THAN TO INSERT IT. THE TECHNICAL REPORT MAKES IT CLEAR THAT THE DEVICE CONFORMS TO SPECIFICATIONS. IT IS DIFFICULT TO DRAW ANY CONCLUSIONS FROM THE X-RAYS. IMAGE 1 SEEMS TO GIVE THE BEST VIEW; THE OTHERS ARE SLIGHTLY OBLIQUE AND AS SUCH DIFFICULT TO INTERPRET. THE NAIL SEEMS TO HAVE ROTATED BUT NOT MOVED OUT WHILE THESE IMAGES WERE TAKEN". CONCLUSION: DESPITE THE DAMAGING SIGNS DETECTED ON THE THREADED PART, THE RETURNED DEVICE WAS FOUND TO BE IN CONFORMANCE TO THE SPECIFICATION. IT COULD FUNCTION AS INTENDED. IT WAS NOT POSSIBLE TO REPLICATE THE PROBLEM OCCURRED DURING THE REMOVAL SURGERY. ORTHOFIX SRL HISTORICAL RECORDS SHOWS THAT NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE CODE. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 0

    THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 183336 (M7 CONICAL MALLET ADAPTOR). BATCH NUMBER: G180555. QUANTITY: 1. DATE OF INITIAL SURGERY: (B)(6) 2020. BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR . SURGERY DESCRIPTION: CORRECTION. PATIENT'S INFORMATION: 14 YEARS, FEMALE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "DEVICE REVEALS TOO WIDE TO ENTER COMPLETELY IN THE NAIL. THE EXTRACTION COULD NOT BE OPERATED. PATIENT WOULD LIKE TO GET THE NAIL OUT.". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (SEE EVENT DESCRIPTION) . THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE. A REPLACEMENT DEVICE WAS NOT IMMEDIATELY AVAILABLE TO COMPLETE SURGERY. THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE (2.5 HOURS INSTEAD OF 1 HOUR). AN ADDITIONAL SURGERY WAS REQUIRED (NOT DEFINED YET) A MEDICAL INTERVENTION WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE AVAILABLE (NOT RECEIVED BY ORTHOFIX SRL) . PRODUCT IS AVAILABLE FOR RETURN. PATIENT CURRENT HEALTH CONDITIONS: OK FOR THE MOMENT. FURTHER INFORMATION RECEIVED ON MARCH 1, 2021 FROM THE SALES REPRESENTATIVE: THE INITIAL SURGERY WAS ON (B)(6) 2020 AND IT WAS THE DATE OF THE NAIL REMOVAL ATTEMPT. I CONFIRM THAT NO SURGERY HAS BEEN SCHEDULED YET. A SECOND DATE HAS NOT ALREADY PLANNED. ON (B)(6) 2021, ORTHOFIX SRL RECEIVED SOME X-RAY IMAGES FROM THE SALES REPRESENTATIVE FURTHER INFORMATION RECEIVED ON MARCH 11, 2021 FROM THE SALES REPRESENTATIVE: THE NAIL HAS BEEN IMPLANTED IN ANOTHER HOSPITAL WITHOUT END CAP. MANUFACTURER REF: (B)(4). DISTRIBUTOR REF: (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE (B)(4) BATCH G180555 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2019, WAS COMPRISED OF 23 DEVICES. 19 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 CODE. TECHNICAL EVALUATION THE TECHNICAL EVALUATION ON THE RETURNED DEVICE, RECEIVED ON (B)(6) 2021, IS CURRENTLY ON GOING. 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 PROVIDED BY LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: (B)(4) (M7 CONICAL MALLET ADAPTOR). BATCH NUMBER: G180555. QUANTITY: 1. HOSPITAL NAME: (B)(6). SURGEON NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2020. BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR. SURGERY DESCRIPTION: CORRECTION. PATIENT'S INFORMATION: (B)(6) YEARS, FEMALE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "DEVICE REVEALS TOO WIDE TO ENTER COMPLETELY IN THE NAIL. THE EXTRACTION COULD NOT BE OPERATED. PATIENT WOULD LIKE TO GET THE NAIL OUT.". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (SEE EVENT DESCRIPTION). THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE. A REPLACEMENT DEVICE WAS NOT IMMEDIATELY AVAILABLE TO COMPLETE SURGERY. THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE (2.5 HOURS INSTEAD OF 1 HOUR). AN ADDITIONAL SURGERY WAS REQUIRED (NOT DEFINED YET). A MEDICAL INTERVENTION WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE AVAILABLE (NOT RECEIVED BY ORTHOFIX SRL). PRODUCT IS AVAILABLE FOR RETURN. PATIENT CURRENT HEALTH CONDITIONS: OK FOR THE MOMENT. MANUFACTURER REF: (B)(4). DISTRIBUTOR REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213463 M7 CONICAL MALLET ADAPTOR M7 CONICAL MALLET ADAPTOR HSB ORTHOFIX SRL G180555

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention