BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANN PH NAIL RT 10X220MM

    MDR report key: 23074147 · Received September 17, 2025

    Report

    Report Number
    0009613350-2025-00708
    Event Type
    Injury
    Date Received
    September 17, 2025
    Date of Event
    August 22, 2025
    Report Date
    September 17, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505919
    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. ANN BLUNT TIP SCREW 4X50MM ITEM# 47248605040 LOT# 3228024. ANN BLUNT TIP SCREW 4X50MM ITEM# 47248605040 LOT# 3228198. ANN BLUNT TIP SCREW 4X52MM ITEM# 47248605240 LOT# 3076792. BLUNT TIP SCREW, ÿ 4X52MM ITEM# 47248605240 LOT# 3207865. BLUNT TIP SCREW, ÿ 4X54MM ITEM# 47248605440 LOT# 3157875. CORTICAL BONE SCREW, ÿ 4X28MM ITEM# 47248612840 LOT# 3240162. CORTICAL BONE SCREW, ÿ 4X30MM ITEM# 47248613040 LOT# 3225546. PROXIMAL HUMERUS NAIL CAP, 0MM ITEM# 47248801000 LOT# 3242939. G2. REPORT SOURCE: JAPAN. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION 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. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. THE REVIEW IDENTIFIED THE FOLLOWING: PHOTO OF A COMPUTER SCREEN SHOWING A FLUOROSCOPIC AP IMAGE OF THE PROXIMAL HUMERUS WITH FIVE INTERLOCKING SCREWS. INTRAMEDULLARY NAIL IN THE HUMERUS SPANNING WHAT APPEARS TO BE A PROXIMAL HUMERAL METADIAPHYSIS FRACTURE. THREE OF THE SCREW HEADS ARE PROUD WITH SUBSTANTIAL BACKOUT OF THE PROXIMAL SCREW. AS THE DEVICES INVOLVED IN THE REPORTED EVENT WERE NOT RETURNED FOR INVESTIGATION, A FURTHER PRODUCT EVALUATION COULD NOT BE PERFORMED AND THE CONDITION OF THE PRODUCTS ARE UNKNOWN. 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. 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 OPERATION WAS PERFORMED WITH ANN NAIL. ONE WEEK AFTER THE INITIAL SURGERY, SURGEON FOUND ONE OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. TWO WEEKS AFTER THE INITIAL SURGERY, ALL OF THE PROXIMAL SCREWS WERE BACKED OUT FROM THE PROPER POSITION AND SUBSEQUENTLY UNDERWENT A REVISION SURGERY, DURING WHICH, THE SURGEON CONFIRMED THAT THE CORELOCK HAD BECOME LOOSE. THEN THE SCREW DEPTH WAS READJUSTED, THE CORELOCK WAS RETIGHTENED, AND THE REVISION WAS COMPLETED. 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
    1636397 ANN PH NAIL RT 10X220MM IMPLANT, TRAUMA HSB ZIMMER GMBH 3174907 00889024505919

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R