BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANN BLUNT TIP SCREW 4X52MM

    MDR report key: 19424440 · Received May 30, 2024

    Report

    Report Number
    0009613350-2024-00202
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    May 13, 2024
    Report Date
    July 16, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    PMA / PMN Number
    K200814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 FOUR SCREWS HAS MIGRATED. THEREFORE, THE MIGRATED SCREW COULD BE ANY OF THE FOLLOWING: 47248605240 - ANN BLUNT TIP SCREW 4X52MM - 3183253; UDI: (B)(4). MANUFACTURING DATE: NOV 22, 2023; EXPIRATION DATE: NOV 22, 2028. 47248603640 - ANN BLUNT TIP SCREW 4X36MM - 3181305 UDI: (B)(4). MANUFACTURING DATE: NOV 2, 2023; EXPIRATION DATE: NOV 2, 2028. 47248603640 - ANN BLUNT TIP SCREW 4X36MM - 3181915; UDI: (B)(4). MANUFACTURING DATE: OCT 30, 2023; EXPIRATION DATE: OCT 30, 2028. 47248603840 - ANN BLUNT TIP SCREW 4X38MM - 3187131; UDI: (B)(4). MANUFACTURING DATE: DEC 15, 2023; EXPIRATION DATE: DEC 15, 2028. D10: 47249616109¿ ANN PROXIMAL HUMERUS NAIL ¿ 3183539 47248603640 ¿ BLUNT TIP SCREW ¿ 3181305 47248603640 ¿ BLUNT TIP SCREW - 3181915 47248603840 ¿ BLUNT TIP SCREW - 3187131 47248612440 ¿ CORTICAL BONE SCREW ¿ 3189216 47248612640 ¿ CORTICAL BONE SCREW ¿ 3185166 47248801000 ¿ ANN PROXIMAL HUMERUS NAIL CAP ¿ 3189244. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H10, H11. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO 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 IS NEEDED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257676 ANN BLUNT TIP SCREW 4X52MM TRAUMA, INSTRUMENTS HSB ZIMMER GMBH N/A 3183253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11