BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUNT TIP SCREW, ÿ 4X38MM

    MDR report key: 18455903 · Received January 5, 2024

    Report

    Report Number
    0009613350-2024-00012
    Event Type
    Injury
    Date Received
    January 5, 2024
    Date of Event
    December 7, 2023
    Report Date
    February 15, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505438
    PMA / PMN Number
    K181827 / K2
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10. CORTICAL BONE SCREW, 4X28MM ITEM# 47248612840 LOT# 3152732. CORTICAL BONE SCREW, 4X28MM ITEM# 47248612840 LOT# 3164731. PROXIMAL HUMERUS NAIL CAP, 0MM ITEM# 47248801000 LOT# 3178851. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2024-00010, 0009613350-2024-00011, 0009613350-2024-00013.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. DEVICES ARE USED FOR TREATMENT. REVIEW OF COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PRODUCTS AND ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATIONS. COMPLAINTS ARE MONITORED THROUGH MONTHLY COMPLAINT REVIEW, IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. X-RAYS RECEIVED: IMAGES ASSESSED, NOT SENDING TO MMI FOR UNABLE TO COORDINATE UNDATED IMAGES TO EVENT, SENDING IMAGES WOULD NOT ENHANCE THE INVESTIGATION. NO SURGICAL REPORT WAS PROVIDED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2024-00010-1. 0009613350-2024-00011-1. 0009613350-2024-00013-1.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN APPROXIMATELY 1 MONTH AGO. AFTER 4 DAYS FROM THE INITIAL, SURGEON FOUND ALL PROXIMAL SCREWS WERE BACKED OUT FROM THE PROPER POSITION. NO REOPERATION DATE HAS BEEN SET, BUT THE ANN WILL BE REMOVED, AND THE RSA WILL BE PERFORMED. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    DILIGENCE IS COMPLETE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986986 BLUNT TIP SCREW, ÿ 4X38MM PROSTHESIS, TRAUMA HSB ZIMMER GMBH N/A 3169752 00889024505438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female