BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FITBONE SUBCUTANEOUS ENERGY RECEIVER

    MDR report key: 20154833 · Received September 6, 2024

    Report

    Report Number
    9680825-2024-00051
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    August 28, 2024
    Report Date
    November 7, 2024
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HSB
    PMA / PMN Number
    K203399
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TECHNICAL EVALUATION THE RETURNED DEVICES, RECEIVED ON SEPTEMBER 6, 2024, WERE EXAMINED BY ORTHOFIX QUALITY ENGINEERING DEPARTMENT. THE DEVICES WERE SUBJECTED TO VISUAL, DIMENSIONAL AND FUNCTIONAL CHECK AS PER ORTHOFIX SPECIFICATION. 1) NAIL CODE 60001468. THE VISUAL CHECK OF THE NAIL DID NOT EVIDENCE ANY ANOMALIES NOR ANY SIGNS OF USE. THE DIMENSIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES. THE FUNCTIONAL CHECK CONFIRMED THE PROBLEM NOTIFIED. THE NAIL IS NOT FUNCTIONING ACCORDING TO SET SPECIFICATIONS. AFTER APPLICATION OF A VOLTAGE HIGHER THAN SPECIFICATIONS, THE NAIL COULD BE THEN ELONGATED, AND NO FURTHER ISSUES RAISED. 2) RECEIVER CODE 60001780. THE VISUAL CHECK DID NOT EVIDENCE ANY ANOMALIES: THE CABLE HAS NO BENDING OR OTHER DEFORMATIONS. THE SILICONE HAS NO DEFECTS, WEAR, OR SIGNS OF DAMAGE. THE SOCKET IS IN GOOD CONDITIONS (SOLDERING STILL INTACT). IN THE FUNCTIONAL CHECK THE DEVICE WAS TESTED WITH DIFFERENT LOADS, AT DIFFERENT DISTANCES AND IN DISTRACTION/RETRACTION MODE. NO ANOMALIES WERE DETECTED. THE DEVICE IS FUNCTIONING AS EXPECTED. CONCLUSIONS 1) NAIL CODE 60001468. THE ANALYSIS PERFORMED ON THE RETURNED NAIL CONFIRMED THE NOTIFIED ISSUE. THE NAIL IS NOT FUNCTIONING ACCORDING TO SET SPECIFICATIONS. AFTER APPLICATION OF A VOLTAGE HIGHER THAN SPECIFICATIONS, THE NAIL COULD BE THEN ELONGATED, AND NO FURTHER ISSUES RAISED. 2) RECEIVER CODE 60001780. THE FUNCTIONAL CHECK PERFORMED DID NOT DETECT ANY MALFUNCTION ON THE RETURNED RECEIVER, WHICH PERFORMS PROPERLY ACCORDING TO THE SET ACCEPTANCE CRITERIA. IT IS LIKELY THAT THE FITBONE NAIL FAILED DUE TO THE PRESENCE OF RESIDUES OF GLUE CLOSE TO MOTOR. GLUE IS USED DURING NAIL ASSEMBLY PROCESS, TO FIX IN POSITION THE GEARMOTOR INTO THE MOTOR HOUSING. IT IS SUGGESTED THAT SOME GLUE INFILTRATED BETWEEN THE MOTOR AND THE GEARBOX, THROUGH THE PLASTIC FLANGE AND REACHED THE MOTOR OUTPUT SHAFT, TEMPORARILY BLOCKING IT MECHANICALLY. THE APPLICATION OF A HIGHER VOLTAGE MADE THE NAIL RESTARTING. ORTHOFIX CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Additional Manufacturer Narrative · 0

    TECHNICAL EVALUATION THE DEVICES INVOLVED IN THIS EVENT HAVE NOT YET BEEN RECEIVED BY ORTHOFIX SRL. ORTHOFIX SRL IS STRICTLY IN CONTACT WITH THE LOCAL DISTRIBUTOR TO HAVE THE DEVICES CONCERNED. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICES BECOME AVAILABLE. AS SOON AS THE RESULTS OF THE INVESTIGATION ARE AVAILABLE, ORTHOFIX WILL PROVIDE A FOLLOW UP REPORT.

    Description of Event or Problem · 0

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: PRODUCTS CODE: 60001468 AND 60001780 (MFR REPORT 9680825-2024-00050 AND 9680825-2024-00051). BATCH NUMBERS: B3903631 AND B4919128, HOSPITAL NAME: (B)(6) HOSPITAL, SURGEON'S NAME: DR. (B)(6), DATE OF INITIAL SURGERY: ON (B)(6) 2024, BODY PART TO WHICH DEVICE WAS APPLIED: LEFT FEMUR, SURGERY DESCRIPTION: LENGTHENING, PATIENT INFORMATION: 14 YEARS, FEMALE, PROBLEM OBSERVED DURING: HOSPITAL PRE-USE INSPECTION, TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "DURING SURGERY, THEY TESTED BOTH THE NAIL AND THE SUBCUTANEOUS RECEIVER BEFORE IMPLANTATION, AND WHEN THIS DID NOT WORK, IT WAS DECIDED TO REPLACE BOTH PRODUCTS". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE (45 MINUTES) AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED COPY OF OPERATIVE REPORTS AND COPY OF X-RAY IMAGES ARE NOT AVAILABLE PRODUCT IS AVAILABLE FOR RETURN. PATIENT CURRENT HEALTH CONDITION: PATIENT IS RECOVERING FROM SURGERY. MANUFACTURER REF: 2024190 DISTRIBUTOR REF: (B)(4).

    Description of Event or Problem · 0

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - PRODUCTS CODE: 60001468 AND 60001780 (MFR REPORT 9680825-2024-00050). BATCH NUMBERS: B3903631 AND B4919128. HOSPITAL NAME: (B)(6). SURGEON'S NAME: DRA. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2024. BODY PART TO WHICH DEVICE WAS APPLIED: LEFT FEMUR. SURGERY DESCRIPTION: LENGTHENING. PATIENT INFORMATION: 14 YEARS, FEMALE. PROBLEM OBSERVED DURING: HOSPITAL PRE-USE INSPECTION. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "DURING SURGERY, THEY TESTED BOTH THE NAIL AND THE SUBCUTANEOUS RECEIVER BEFORE IMPLANTATION, AND WHEN THIS DID NOT WORK, IT WAS DECIDED TO REPLACE BOTH PRODUCTS". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE (45 MINUTES). AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPY OF OPERATIVE REPORTS AND COPY OF X-RAY IMAGES ARE NOT AVAILABLE. PRODUCT IS AVAILABLE FOR RETURN. PATIENT CURRENT HEALTH CONDITION: PATIENT IS RECOVERING FROM SURGERY. MANUFACTURER REF: (B)(4) DISTRIBUTOR REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1886677 FITBONE SUBCUTANEOUS ENERGY RECEIVER FITBONE SUBCUTANEOUS ENERGY RECEIVER HSB ORTHOFIX SRL

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female Other