BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANN BLUNT TIP SCREW 4X40MM

    MDR report key: 20015235 · Received August 21, 2024

    Report

    Report Number
    0009613350-2024-00384
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    August 5, 2024
    Report Date
    September 5, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505445
    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 SCREWS HAS MIGRATED. THEREFORE, THE MIGRATED SCREW COULD BE ANY OF THE FOLLOWING: 47248604040 ¿ BLUNT TIP SCREW ¿ 3164756. UDI: (B)(4). MANUFACTURING DATE: JUN 26, 2023. EXPIRATION DATE: JUN 26, 2028. 47248603840 ¿ ANN BLUNT TIP SCREW 4X38MM ¿ 3149853. (B)(4). MANUFACTURING DATE: MAR 2, 2023. EXPIRATION DATE: MAR 2, 2028. 47248603840 ¿ ANN BLUNT TIP SCREW 4X38MM ¿ 3149853. (B)(4). MANUFACTURING DATE: MAR 2, 2023. EXPIRATION DATE: MAR 2, 2028. D10: 47-2486-038-40 ANN BLUNT TIP SCREW 4X38MM 3149853. 47-2486-038-40 ANN BLUNT TIP SCREW 4X38MM 3149853. 47-2486-126-40 ANN CORT BONE SCREW 4 X 26MM 3170717. 47-2486-128-40 ANN CORT BONE SCREW 4 X 28MM 3160726. 47-2488-010-00 AFFIXUS PH NL CAP 0MM 3169765. 47-2496-160-09 PROXIMAL HUMERUS, RIGHT, ÿ 9X160MM 3141969. G2: FOREIGN: 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 MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS AND THE PART AND LOT COMBINATIONS. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER 9 MONTHS FROM THE INITIAL IMPLANTATION ONE OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. THE PATIENT'S HEALTH IS FINE, THE SCREW HAS NOT BEEN REMOVED AND NO REVISION SURGERY HAS BEEN PERFORMED. THERE IS NO REPORTED HARM OR INJURY TO THE PATIENT, HOWEVER THIS MALFUNCTION HAS CAUSED A SERIOUS INJURY IN THE PAST. DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE ALL AVAILABLE ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2179004 ANN BLUNT TIP SCREW 4X40MM TRAUMA IMPLANT HSB ZIMMER GMBH N/A 3164756 00889024505445

    Patients

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