BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THREADED WIRE STERILE (PACK OF 2)

    MDR report key: 12390914 · Received August 31, 2021

    Report

    Report Number
    9680825-2021-00055
    Event Type
    Malfunction
    Date Received
    August 31, 2021
    Date of Event
    January 27, 2020
    Report Date
    October 20, 2021
    Manufacturer
    ORTHOFIX SRL
    Product Code
    KTT
    PMA / PMN Number
    K113770
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ORTHOFIX SRL WOULD LIKE TO COMMUNICATE THAT BEFORE AUGUST 20, 2021 NO NOTIFICATIONS WERE RECEIVED REGARDING THIS EVENT OCCURRED IN THE YEAR 2020. ANALYSIS OF HISTORICAL RECORDS: THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED. UNFORTUNATELY ALSO THE CODE AND THE LOT NUMBER HAVE NOT BEEN MADE AVAILABLE AND THEREFORE IT WAS NOT POSSIBLE TO PERFORM THE VERIFICATION OF THE HISTORICAL DATA. TECHNICAL ANALYSIS: A TECHNICAL EVALUATION OF THE DEVICE USED WAS NOT PERFORMED AS THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR THE INVESTIGATION. THE TECHNICAL EVALUATION WILL BE PERFORMED SHOULD THE DEVICE BECOME AVAILABLE. FINAL COMMENTS: IT WAS NOT POSSIBLE TO PERFORM THE TECHNICAL ANALYSIS AS THE DEVICE INVOLVED WAS NOT RETURNED TO ORTHOFIX SRL. IT WAS NOT POSSIBLE TO PERFORM THE MEDICAL EVALUATION AS NO X-RAY IMAGES WERE MADE AVAILABLE. CONSIDERING THE LACK OF INFORMATION, IT IS NOT POSSIBLE TO CONDUCT ANY INVESTIGATION AND THEREFORE TO DRAW ANY CONCLUSION IN REGARDS TO THE EVENT OCCURRED. SHOULD FURTHER INFORMATION AND/OR THE DEVICE CONCERNED BECOME AVAILABLE, ORTHOFIX SRL WILL RE-OPEN THE INVESTIGATION. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 0

    ON AUGUST 20, 2021 ORTHOFIX SRL RECEIVED A REQUEST FOR INFORMATION FROM PATIENT M.M. IN RELATION TO THE TECHNICAL CHARACTERISTICS OF THE RAW MATERIAL OF A GALAXY DEVICE FRAGMENT LEFT IN HIS BONE DURING SURGERY. BELOW IS THE INFORMATION AVAILABLE ON THE CASE: ON (B)(6) 2020, THE PATIENT WAS OPERATED AT HOSPITAL "(B)(6) " IN ROME, FOR A DISPLACED FRACTURE OF THE HUMERAL TROCHITIS, WITH AN ORTHOFIX GALAXY DEVICE. DURING THE FIXATION SURGERY A PIECE OF THIS MECHANISM BROKE AND REMAINED INSERTED IN THE BONE. ON AUGUST 24, 2021 ORTHOFIX SRL RECEIVED LIST OF COMPONENTS USED DURING SURGERY. ON SEPTEMBER 27, 2021 ORTHOFIX SRL RECEIVED COPY OF THE SURGERY REPORT AND THE FOLLOWING FURTHER INFORMATION: BODY PART TO WHICH DEVICE WAS APPLIED: SHOULDER, RIGHT. SURGERY DESCRIPTION: FRACTURE. PATIENT INFORMATION: 48 YEAR-OLD, MALE, PREVIOUS HEALTH CONDITIONS: GOOD. PROBLEM OBSERVED DURING: TREATMENT. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: AFTER POSITIONING THE WIRE, FOLLOWING A REDUCTION MANEUVER, THE WIRE BROKE. THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. - 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. - COPY OF THE OPERATIVE REPORT IS AVAILABLE. - COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. - PRODUCT IS NOT AVAILABLE FOR RETURN. - PATIENT CURRENT HEALTH CONDITION: N/A. -COMMENTS: RETURNED AD INTEGRUM. EXTRACT FROM OPERATIVE REPORT: IT IS CONFIRMED WITH X-RAY PROJECTION IN THREE PLANES THAT THE POSITION OF THE THREADED PORTION OF THE WIRE, WHICH WAS LEFT IN THE BONE IN THE PREVIOUS SURGERY AND THEREFORE ALREADY KNOWN, CURRENTLY APPEARS UNCHANGED AND DOES NOT PROTRUDE OR COMPRESS THE NEIGHBORING STRUCTURES. IT IS THEREFORE DECIDED TO LEAVE THIS PORTION OF WIRE IN THE BONE, AS AGREED PRE-OPERATIVELY WITH THE PATIENT. THE RANGE OF MOTION AND STABILITY OF THE SHOULDER ARE TESTED AND APPEAR SATISFACTORY. ON OCTOBER 12, 2021 ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE TERRITORY MANAGER: -NO X-RAY IMAGES WILL BE MADE AVAILABLE. MANUFACTURER REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ORTHOFIX SRL WOULD LIKE TO COMMUNICATE THAT BEFORE AUGUST 20, 2021 NO NOTIFICATIONS WERE RECEIVED REGARDING THIS EVENT OCCURRED IN THE YEAR 2020. TECHNICAL EVALUATION: THE DEVICE INVOLVED HAS NOT BEEN RETURNED TO ORTHOFIX SRL. AS SOON THE DEVICE IS MADE AVAILABLE, ORTHOFIX SRL WILL PERFORM THE TECHNICAL ANALYSIS. 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 FURTHER DETAILS OF THE EVENT BECOME AVAILABLE. ORTHOFIX SRL HAS REQUESTED FURTHER INFORMATION ON THE EVENT, I.E. CODE REFERENCE AND LOT NUMBER OF THE DEVICE INVOLVED, PATIENT'S INFORMATION, POTENTIAL ADVERSE EFFECTS ON PATIENT, COPY OF THE X-RAYS OF THE ORIGINAL FRACTURE PREOPERATIVELY AND POSTOPERATIVE. UNFORTUNATELY, NO OTHER INFORMATION WAS RECEIVED SO FAR. 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

    ON AUGUST 20, 2021 ORTHOFIX SRL RECEIVED A REQUEST FOR INFORMATION FROM PATIENT M.M. IN RELATION TO THE TECHNICAL CHARACTERISTICS OF THE RAW MATERIAL OF A GALAXY DEVICE FRAGMENT LEFT IN HIS BONE DURING SURGERY. BELOW IS THE INFORMATION AVAILABLE ON THE CASE: ON (B)(6) 2020, THE PATIENT WAS OPERATED AT HOSPITAL (B)(6) IN (B)(6), FOR A DISPLACED FRACTURE OF THE HUMERAL TROCHITIS, WITH AN ORTHOFIX GALAXY DEVICE. DURING THE FIXATION SURGERY A PIECE OF THIS MECHANISM BROKE AND REMAINED INSERTED IN THE BONE. MANUFACTURER REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294899 THREADED WIRE STERILE (PACK OF 2) THREADED WIRE STERILE (PACK OF 2) KTT ORTHOFIX SRL 99-93100 -ITEM NOT CONFIRMED

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR