BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCB®, SCREW, SELF-TAPPING, ø 4.0 MM, 32 MM

    MDR report key: 24277136 · Received February 6, 2026

    Report

    Report Number
    0009613350-2026-00043
    Event Type
    Injury
    Date Received
    February 6, 2026
    Date of Event
    November 12, 2024
    Report Date
    March 25, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024296176
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10. UNKNOWN SCREW ITEM# UNKNOWN LOT# UNKNOWN. NCB®, SCREW, SELF-TAPPING, ø 4.0 MM, 32 MM ITEM# 0203155032 LOT# 3009474. NCB®, SCREW, SELF-TAPPING, ø 4.0 MM, 30 MM ITEM# 0203155030 LOT# 3012708. NCB PP DIS FEM PLT R12H L278MM ITEM# 02.03264.012 LOT# 3082932. G2. REPORT SOURCE: POLAND. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. 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 RETURNED FOR INVESTIGATION. ALL THREE RETURNED SCREWS SHOWED SIGNS OF USE AND WEAR/TEAR, WITH DAMAGE TO THE HEX/HEAD FEATURES, INCLUDING SCRATCHING AND GOUGING, AND ALL THREE DEVICES WERE FRACTURED. THE 32 MM SCREW (L/N 3009474) HAD DAMAGE ALONG THE UPPER EDGES AND CORNERS OF THE INTERNAL HEX. THE 30 MM SCREW (L/N 3012708) HAD DAMAGE TO THE UPPER EDGES OF THE HEX FEATURE. THE THIRD SCREW HAD NO ETCH MARKING, SO THE LOT AND PART INFORMATION ARE UNKNOWN. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORIES FOUND NO ADDITIONAL RELATED COMPLAINTS AND THE ITEMS OR THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THE ENTIRE RIGHT FEMORAL OPERATIVE SITE AND HARDWARE ARE NOT INCLUDED. THE VISUALIZED FIXATION PLATE IS OBLIQUELY ORIENTED AND SEPARATED FROM THE FEMUR. THE HEAD OF THE MOST PROXIMAL SCREW IS FRACTURED AND REMAINS AT THE PLATE. THE SECOND SCREW IS NOT FRACTURED BUT THE SCREW HEAD HAS PASSED THROUGH THE PLATE. THE TWO MOST PROXIMAL FIXATION SCREWS REMAIN WITHIN THE FEMUR AND THE MORE DISTAL SCREW IS PARTIALLY RETRACTED FROM THE FEMUR. THERE IS AN INCOMPLETELY VISUALIZED FEMORAL FRACTURE. RETRACTED PROXIMAL FEMORAL FIXATION PLATE WITH PROXIMAL SCREW FRACTURE AND SCREW POSITION AS NOTED. THE ENTIRE PLATE AND SCREW FIXATION IS NOT INCLUDED ON THE IMAGE. THE PROXIMAL SCREW IS FRACTURED AND THE SECOND SCREW PASSES THROUGH THE PLATE. ON THIS LIMITED IMAGE WITHOUT COMPLETE VISUALIZATION OF THE FEMORAL FRACTURE AND FIXATION HARDWARE, TRAUMA TO CAUSE THE SCREW FACTURE CANNOT BE DETERMINED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 NEEDED A REVISION PROCEDURE DUE TO FRACTURE OF THE SCREW AND AN ISSUE WITH THE PASSAGE OF THE SCREW THROUGH THE HOLE IN THE PLATE. 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
    339919 NCB®, SCREW, SELF-TAPPING, ø 4.0 MM, 32 MM IMPLANT, TRAUMA HSB ZIMMER GMBH 3009474 00889024296176

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11 NARRATIVE.