BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUNT TIP SCREW, ÿ 4X40MM

    MDR report key: 21021097 · Received December 26, 2024

    Report

    Report Number
    0009613350-2024-00625
    Event Type
    Injury
    Date Received
    December 26, 2024
    Date of Event
    December 4, 2024
    Report Date
    April 10, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505445
    PMA / PMN Number
    K200814
    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.BLUNT TIP SCREW, ÿ 4X42MM ITEM# 47248604240 LOT# 3207863. BLUNT TIP SCREW, ÿ 4X40MM ITEM# 47248604040 LOT# 3207884. BLUNT TIP SCREW, ÿ 4X58MM ITEM# 47248605840 LOT# 3189215. PROXIMAL HUMERUS, LEFT, ÿ 11X160MM ITEM# 47249616111 LOT# 3193588. CORTICAL BONE SCREW, ÿ 4X30MM ITEM# 47248613040 LOT# 3197007. CORTICAL BONE SCREW, ÿ 4X32MM ITEM# 47248613240 LOT# 3189217. WASHER SMALL ITEM# 47248800004 LOT# 3177551. PROXIMAL HUMERUS NAIL CAP, 0MM ITEM# 47248801000 LOT# 3200542. G2 REPORT SOURCE: JAPAN. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR 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. THE PRODUCTS INVOLVED IN THE REPORTED EVENT WERE NOT RETURNED FOR INVESTIGATION; HOWEVER, PICTURES WERE PROVIDED AND REVIEWED. ALL SCREWS EXHIBIT FLATTENED AND POLISHED THREADS. THE FEMALE THREADS ON THE NAIL WHERE THE SCREW ARE INSERT-ED, SHOW SIGNS DEFORMATION, MOST LIKELY DUE TO THE ENGAGEMENT WITH THE SCREWS. 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. SIX RADIOGRAPHS WERE RECEIVED AND ASSESSED BY A RADIOLOGIST. ON A PRE-REVISION SURGERY IMAGE, A TRANSVERSE DISPLACED HUMERAL NECK FRACTURE IS VISIBLE. AN IMAGE TAKEN IMMEDIATELY AFTER IMPLANTATION, SHOWS THAT INTRAMEDULLARY SCREW AND NAIL FIXATION HAS BEEN PERFORMED, AND THE ALIGNMENT IS IMPROVED. ON SUBSEQUENTLY FOLLOW-UP IMAGES, PROGRESSIVE RETRACTION OF THE SCREWS WITHOUT CHANGE IN FRACTURE ALIGNMENT IS NOTED. BONE QUALITY IS OSTEOPENIC ON ALL IMAGES. BASED ON THE PROVIDED RADIOGRAPHS, THE REPORTED OF THE SCREWS MIGRATED COULD BE CONFIRMED. BASED ON THE PROVIDED RADIOGRAPHS, THE REPORTED EVENT OF THE SCREWS MIGRATION COULD BE CONFIRMED. THE PROVIDED PICTURES SHOW WEAR AND DEFORMATION ON THE DEVICES, WHICH ARE CONSISTENT WITH THE MIGRATION. HOW-EVER, AS THE DEVICES WERE NOT RETURNED, FURTHER EVALUATION COULD NOT BE PERFORMED. BASED ON THE INVESTIGATION, IT CAN BE ASSUMED THAT THE MIGRATION OF THE SCREWS MAY HAVE BEEN INFLUENCED BY MULTIPLE FACTORS, POTENTIALLY INCLUDING PATIENT¿S CONDITION, BEHAVIOR OR IMPLANTATION PROCEDURE. HOWEVER, IF AND TO WHAT EXTENT ANY OF THESE ASPECTS MAY HAVE INFLUENCED THE MIGRATION OF THE SCREWS REMAINS UNKNOWN, AND THE INVOLVEMENT OF OTHER FACTORS CANNOT BE RULED OUT. BASED ON SIMILAR EVENTS, AN ADDITIONAL DEEPER INVESTIGATION WAS PERFORMED WHICH IDENTIFIED THAT THE CORELOCK MECHANISM OF THE AFFIXUS NAIL COULD BE A POTENTIAL CONTRIBUTING FACTOR. IN CONCLUSION, AS THE CAUSE MAY BE MULTIFACTORIAL AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE MIGRATION OF THE SCREWS. 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 ANN NAIL SURGERY WAS PERFORMED. SUBSEQUENTLY, AFTER 1 MONTH FROM THE INITIAL SURGERY, THE SURGEON FOUND THAT ALL PROXIMAL SCREWS HAD MIGRATED OUT OF THE PROPER POSITION. THE PATIENT COMPLAINED OF PAIN AND REVISION SURGERY WAS PERFORMED AND REMOVED ALL IMPLANTS. 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
    2449414 BLUNT TIP SCREW, ÿ 4X40MM IMPLANT, TRAUMA HSB ZIMMER GMBH N/A 3193667 00889024505445

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Hospitalization| R SEE H11 NARRATIVE.