BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANN BLUNT TIP SCREW 4X44MM

    MDR report key: 22011164 · Received May 13, 2025

    Report

    Report Number
    0009613350-2025-00369
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    April 17, 2025
    Report Date
    July 23, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    UDI-DI
    00889024505469
    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. ANN BLUNT TIP SCREW 4X46MM ITEM#: 47248604640, LOT#: 3221605. ANN BLUNT TIP SCREW 4X48MM ITEM#: 47248604840, LOT#: 3200538. PROXIMAL HUMERUS, RIGHT, 11X160MM ITEM#: 4724961601,1 LOT#: 3216532. BLUNT TIP SCREW, 4X58MM ITEM#: 47248605840, LOT#: 3201663. CORTICAL BONE SCREW, 4X32MM ITEM#: 47248613240, LOT#: 3203252. CORTICAL BONE SCREW, 4X34MM ITEM#: 47248613440, LOT#: 3176667. 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 WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H10, H11. CORRECTED: A1, E1. NO PRODUCT WAS RETURNED BUT PICTURES OF THE SCREWS WERE PROVIDED. VISUAL EXAMINATION OF THE RECEIVED PROXIMAL SCREWS SHOWS FLATTENED AND POLISHED THREADS, LIKELY OCCURRING DUE TO DIRECT CONTACT BETWEEN THE SCREW AND THE NAIL. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. DEVICES ARE USED FOR TREATMENT. THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. THE SURGICAL TECHNIQUE EXPLAINS THAT THE LOCKING OF THE CORELOCK IS DONE USING THE CORELOCK DRIVER WITH TORQUE LIMITING HANDLE. "TURN SLOWLY CLOCKWISE TO TIGHTEN ANDENGAGE THE CORELOCK MECHANISM UNTIL A CLICK IS FELT FROM THE TORQUE LIMITING HANDLE." REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATIONS. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. IMAGING OF THE RIGHT SHOULDER INCLUDES A PRE-IMPLANTATION VIEW, IMMEDIATE POSTOPERATIVE VIEWS, AND PRE-REVISION VIEWS. THE PRE-IMPLANTATION IMAGE SHOWS OSTEOPENIA AND A SUBTLE FRACTURE OF THE PROXIMAL HUMERAL DIAPHYSIS, WITH INFERIOR SUBLUXATION OF THE HUMERAL HEAD RELATIVE TO THE GLENOID. IMMEDIATE POSTOPERATIVE IMAGING DEMONSTRATES PLACEMENT OF AN INTRAMEDULLARY ROD IN THE HUMERUS WITH FOUR PROXIMAL AND TWO DISTAL INTERLOCKING SCREWS, WITH THE FRACTURE STILL VISIBLE. PRE-REVISION IMAGES SHOW PERSISTENT FRACTURE LINES, OSTEOPENIA, AND LOOSENING WITH PARTIAL WITHDRAWAL OF SEVERAL PROXIMAL SCREWS. OVERALL, THERE IS EVIDENCE OF ORTHOPEDIC HARDWARE IN THE RIGHT HUMERUS WITH LOOSENING OF THE PROXIMAL SCREWS. BASED ON THE PROVIDED RADIOGRAPHS, THE REPORTED EVENT COULD BE CONFIRMED. 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 THE PATIENT HAD AN INITIAL SURGERY WITH ANN NAIL. SUBSEQUENTLY, AFTER 4 WEEKS FROM THE INITIAL SURGERY, THE SURGEON FOUND THAT 3 PROXIMAL SCREWS HAD MIGRATED OUT OF THE PROPER POSITION. THE PATIENT COMPLAINED OF PAIN AND REVISION SURGERY WAS PERFORMED TO REMOVE THESE SCREWS. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180737 ANN BLUNT TIP SCREW 4X44MM IMPLANT, TRAUMA HRS ZIMMER GMBH 3209521 00889024505469

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention| H SEE H11 NARRRATIVE.