BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUNT TIP SCREW, ÿ 4X40MM

    MDR report key: 19313593 · Received May 14, 2024

    Report

    Report Number
    0009613350-2024-00172
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    April 16, 2024
    Report Date
    August 2, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    PMA / PMN Number
    K200814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): D4: PRODUCT ID WAS PROVIDED FOR FOUR SCREWS HOWEVER, IT IS UNKNOWN WHICH OF THE FIVE SCREWS HAS MIGRATED. THEREFORE, THE MIGRATED SCREW COULD BE ANY OF THE FOLLOWING: 47248604040 - BLUNT TIP SCREW, ÿ 4X40MM - 3178838, UDI: (B)(4), MANUFACTURING DATE: OCT 24, 2023, EXPIRATION DATE: OCT 24, 2028. 47248604440 - ANN BLUNT TIP SCREW 4X44MM - 3172291, UDI: (B)(4), MANUFACTURING DATE: AUG 29, 2023, EXPIRATION DATE: AUG 29, 2028. 47248604440 - ANN BLUNT TIP SCREW 4X44MM - 3174914, UDI: (B)(4), MANUFACTURING DATE: SEP 29, 2023, EXPIRATION DATE: SEP 29, 2028. 47248604440 - ANN BLUNT TIP SCREW 4X44MM - 3180632, UDI: (B)(4), MANUFACTURING DATE: OCT 16, 2023, EXPIRATION DATE: OCT 16, 2028. 47248605440 - ANN BLUNT TIP SCREW 4X54MM - 3163116, UDI: (B)(4), MANUFACTURING DATE: JUN 17, 2023, EXPIRATION DATE: JUN 17, 2028. D10: 47249616009 ¿ ANN PROXIMAL HUMERUS NAIL ¿ 3183531, 47248604040 ¿ BLUNT TIP SCREW ¿ 3178838, 47248604440 ¿ BLUNT TIP SCREW ¿ 3172291, 47248604440 ¿ BLUNT TIP SCREW - 3174914, 47248604440 ¿ BLUNT TIP SCREW ¿ 3180632, 47248605440 ¿ BLUNT TIP SCREW ¿ 3163116, 47248613240 ¿ CORTICAL BONE SCREW ¿ 3173383 (X2), 47248801000 ¿ ANN PROXIMAL HUMERUS NAIL CAP ¿ 3185235, 47248800004 ¿ ANN WASHER SMALL ¿ 3091601. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PRODUCTS AND ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATIONS. IT CAN BE ASSUMED THAT MULTIPLE CONTRIBUTING FACTORS, RELATED TO EITHER PATIENT CONDITION AND BEHAVIOR OR IMPLANTATION PROCEDURE, CONTRIBUTED TO THE MIGRATION OF THE SCREWS. IF AND TO WHAT EXTENT ANY OF THESE ASPECTS MAY HAVE INFLUENCED THE MIGRATION OF THE SCREW REMAINS UNKNOWN. AN ADDITIONAL DEEPER INVESTIGATION WAS PERFORMED WHICH IDENTIFIED THE DESIGN LIMITATION OF THE CORELOCK MECHANISM OF THE AFFIXUS NAIL AS A POTENTIAL CONTRIBUTING FACTOR. AS PART OF THE DEEPER INVESTIGATION, A SCIENTIFIC LITERATURE SEARCH WAS CONDUCTED AND A SYSTEMATIC REVIEW OF THE OUTCOME OF INTRAMEDULLARY NAILING FOR ACUTE PROXIMAL HUMERUS FRACTURE SHOWED THAT SCREW MIGRATION AND PERFORATION INTO THE JOINT IS THE SECOND MOST COMMON COMPLICATION FOLLOWING SECONDARY LOSS OF REDUCTION. IN ADDITION, SCIENTIFIC LITERATURE OF COMPETITOR AND PREDICATE DEVICES WERE ASSESSED. THIS REVIEW HAS SHOWN THAT THE AFFIXUS® NATURAL NAIL® PROXIMAL HUMERAL SYSTEM PERFORMS BETTER AND/OR IN EQUAL RANGE IN COMPARISON WITH LEGALLY MARKETED SIMILAR DEVICES. IN CONCLUSION, AS THE CAUSE MAY BE MULTIFACTORIAL AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE MIGRATION OF THE SCREW. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). G2: REPORT SOURCE JAPAN THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOUR WEEKS POST-IMPLANTATION, SURGEON FOUND ONE OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. THE SURGEON WILL KEEP AN EYE ON THE PATIENT CONDITION MOVING FORWARD, AS NO REVISION WILL BE PLANNED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707666 BLUNT TIP SCREW, ÿ 4X40MM TRAUMA, INSTRUMENTS HSB ZIMMER GMBH N/A 3178838

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11 NARRATIVE.