BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL HUMERUS, RIGHT, LONG, ÿ 8.5X220MM

    MDR report key: 20522110 · Received October 24, 2024

    Report

    Report Number
    0009613350-2024-00497
    Event Type
    Injury
    Date Received
    October 24, 2024
    Date of Event
    September 18, 2024
    Report Date
    November 14, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505902
    PMA / PMN Number
    K181827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).D10. BLUNT TIP SCREW, ÿ 4X38MM ITEM# 47248603840 LOT# 3200109.BLUNT TIP SCREW, ÿ 4X38MM ITEM# 47248603840 LOT# 3202502.BLUNT TIP SCREW, ÿ 4X36MM ITEM# 47248603640 LOT# 3185167.CORTICAL BONE SCREW, ÿ 4X24MM ITEM# 47248612440 LOT# 3197002.CORTICAL BONE SCREW, ÿ 4X26MM ITEM# 47248612640 LOT# 3200539. PROXIMAL HUMERUS NAIL CAP, ÿ 10.5X2.5MM ITEM# 47248801002 LOT# 3189231.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 THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS AND THE PART AND LOT COMBINATIONS. COMPLAINTS ARE MONITORED IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. ASSESSMENT OF IMAGING: 9/2/24- AN INTRAMEDULLARY NAIL WITH PROXIMAL AND DISTAL SCREWS TRAVERSES A RIGHT HUMERAL DIAPHYSEAL FRACTURE. ALIGNMENT IS ANATOMIC. 9/18/24- SINCE PRIOR EXAM 2 OF THE 3 PROXIMAL FIXATION SCREWS HAVE SIGNIFICANTLY RETRACTED. NAIL POSITION IS UNCHANGED. WHILE THE VIEWS ARE NOT IDENTICAL, THERE MAY BE SLIGHT INTERVAL INCREASE IN FRACTURE ANGULATION. 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. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT AS THIS ISSUE WAS ALREADY ADDRESSED IN A CORRECTIVE ACTION. 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 AN INITIAL OPERATION WAS PERFORMED WITH ANN NAIL SYSTEM AND AFTER 3 WEEKS, SURGEON FOUND TWO OF THE PROXIMAL SCREWS WERE BACKED OUT FROM THE PROPER POSITION. THE SURGEON KEEPS AN EYE ON THE PATIENT CONDITION AS WELL AS NO REVISION WILL BE PLANNED SO FAR. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1736586 PROXIMAL HUMERUS, RIGHT, LONG, ÿ 8.5X220MM IMPLANT, TRAUMA HSB ZIMMER GMBH N/A 3178811 00889024505902

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female SEE H11 NARRATIVE.