BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAG SCREW GRADUAL REAMER

    MDR report key: 20891352 · Received December 10, 2024

    Report

    Report Number
    9680825-2024-00067
    Event Type
    Injury
    Date Received
    December 10, 2024
    Date of Event
    November 28, 2024
    Report Date
    April 8, 2025
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HSB
    PMA / PMN Number
    K161466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TECHNICAL EVALUATION: THE RETURNED DEVICE WAS EXAMINED BY ORTHOFIX SRL QUALITY OPERATIONS DEPARTMENT. THE VISUAL CHECK CONFIRMED THE PROBLEM NOTIFIED: THE TIP OF THE RETURNED DEVICE IS BROKEN. THE TIP WAS LEFT IN PATIENT'S BONE. SIGNS OF USE WERE DETECTED ON THE DEVICE. THE DIMENSIONAL CHECK AND THE MATERIAL CONFORMITY CHECK DID NOT EVIDENCE ANY ANOMALIES. IT WAS NOT POSSIBLE TO PERFORM THE FUNCTIONAL CHECK AS THE DEVICE IS BROKEN. ANALYSIS OF MANUFACTURING RECORDS CONFIRMED THAT THE NOTICED DEVICE WAS RELEASED AS CONFORMING ACCORDING TO SPECIFICATIONS. THE BROKEN REAMER WAS SENT TO AN EXTERNAL LABORATORY FOR THE RAW MATERIAL VERIFICATION AND FAILURE INVESTIGATION: THE FRACTURE ANALYSIS AND EXAMINATION OF THE SURROUNDING AREAS (INCLUDING OTHER EXISTING CUTTING EDGES) REVEALS THAT THE DAMAGE OCCURRED DUE TO A COLLISION BETWEEN THE END DRILL AND A TITANIUM ALLOY COMPONENT DURING THE DRILLING OPERATION, INVOLVING BOTH ADVANCEMENT AND ROTATION OF THE TOOL. INDEED, TITANIUM ALLOY RESIDUES (WITH ALUMINUM IN THE ALLOY) ARE PRESENT ON BOTH THE INTACT CUTTING EDGES, INCLUDING THE TIP OF THE END DRILL AND THE RADIAL CUTTING EDGES. THE FRACTURE PROPAGATION DIRECTION, AS INDICATED BY THE CHEVRON MARKS, IS CONSISTENT WITH THE DIRECTION OF ROTATION OF THE END DRILL. FINAL COMMENTS: BASED ON THE EVIDENCE COLLECTED AND CONSIDERING THAT THE NAIL WAS MADE OF TITANIUM ALLOY, IT CANNOT BE RULED OUT THAT THE NOTIFIED FAILURE COULD BE DUE TO ABNORMAL CONTACT BETWEEN THE DRILL AND THE NAIL. IN PARTICULAR, THE COLLISION LIKELY OCCURRED DUE TO (I) IMPERFECT ALIGNMENT BETWEEN THE DRILLING GUIDE AND THE NAIL HOLE AND/OR (II) MISSING REMOVAL OF THE GUIDE WIRE FROM THE NAIL. ACCORDING TO THE RELEVANT OPERATIVE TECHNIQUE HF-1501-OPT, THE GUIDE WIRE HAS TO BE REMOVED AFTER NAIL INSERTION THROUGH THE ENTRY POINT AND POSITIONING INTO THE MEDULLARY CANAL AT THE APPROPRIATE DEPTH. GUIDE WIRE REMOVAL MUST OCCUR BEFORE PROXIMAL LOCKING STAGE. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Additional Manufacturer Narrative · 0

    TECHNICAL EVALUATION: THE DEVICE INVOLVED IN THIS EVENT HAS NOT YET BEEN RECEIVED BY ORTHOFIX SRL. ORTHOFIX SRL IS STRICTLY IN CONTACT WITH THE LOCAL DISTRIBUTOR TO HAVE THE DEVICE CONCERNED. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICE BECOMES AVAILABLE. AS SOON AS FURTHER INFORMATION AND/OR 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 · 0

    THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: (B)(6) - SURGEON'S NAME: DR (B)(6) - DATE OF INITIAL SURGERY: (B)(6) 2024 - BODY PART TO WHICH DEVICE WAS APPLIED: PROX FEMUR NECK - SURGERY DESCRIPTION: FRACTURE TREATMENT - PATIENT'S INFORMATION: 42-YEAR-OLD, MALE, WEIGHT 65 KG. - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRA-OPERATIVE - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM - EVENT DESCRIPTION: LAG SCREW DRILL (BLUE) BROKE OFF INSIDE PATIENT WHEN DRILLING. BROKEN DRILL BIT WAS NOT RETRIEVED FROM THE PATIENT. THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: UN-RETRIEVED DEVICE FRAGMENTS, LEFT WITHIN THE PATIENT - THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE - THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: 1 HOUR - AN ADDITIONAL SURGERY WAS NOT REQUIRED: CURRENTLY NO, BUT IF THE PATIENT SHOWS SIGNS OF IRRITATION THE BIT WILL HAVE TO BE REMOVED. - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED - COPY OF OPERATIVE REPORTS IS NOT AVAILABLE - COPY OF X-RAY IMAGES IS NOT AVAILABLE - DEVICE WAS NOT AT ITS FIRST USE - PATIENT'S CURRENT HEALTH CONDITION: DISCHARGED AND RECOVERING AT HOME UNTIL FURTHER NOTICE. ORTHOFIX SRL REF: (B)(4). DISTRIBUTOR REF: (B)(4).

    Description of Event or Problem · 0

    THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: (B)(6) HOSPITAL, (B)(6), SOUTH AFRICA. - SURGEON'S NAME: DR (B)(6). - DATE OF INITIAL SURGERY: (B)(6) 2024. - BODY PART TO WHICH DEVICE WAS APPLIED: PROX FEMUR NECK. - SURGERY DESCRIPTION: FRACTURE TREATMENT. - PATIENT'S INFORMATION: 42-YEAR-OLD, MALE, WEIGHT 65 KG. - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRA-OPERATIVE. - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: LAG SCREW DRILL (BLUE) BROKE OFF INSIDE PATIENT WHEN DRILLING. BROKEN DRILL BIT WAS NOT RETRIEVED FROM THE PATIENT. THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: UN-RETRIEVED DEVICE FRAGMENTS, LEFT WITHIN THE PATIENT. - THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. - THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: 1 HOUR. - AN ADDITIONAL SURGERY WAS NOT REQUIRED: CURRENTLY NO, BUT IF THE PATIENT SHOWS SIGNS OF IRRITATION THE BIT WILL HAVE TO BE REMOVED. - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. - COPY OF OPERATIVE REPORTS IS NOT AVAILABLE. - COPY OF X-RAY IMAGES IS NOT AVAILABLE. - DEVICE WAS NOT AT ITS FIRST USE. - PATIENT'S CURRENT HEALTH CONDITION: DISCHARGED AND RECOVERING AT HOME UNTIL FURTHER NOTICE. ORTHOFIX SRL REF: (B)(4). DISTRIBUTOR REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2476605 LAG SCREW GRADUAL REAMER LAG SCREW GRADUAL REAMER HSB ORTHOFIX SRL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention