BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUNT TIP SCREW, ÿ 4X48MM

    MDR report key: 21925015 · Received April 29, 2025

    Report

    Report Number
    0009613350-2025-00349
    Event Type
    Injury
    Date Received
    April 29, 2025
    Date of Event
    April 3, 2024
    Report Date
    October 21, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505483
    PMA / PMN Number
    K200814
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): G2: REPORT SOURCE SWITZERLAND. D4: PRODUCT ID WAS PROVIDED FOR FOUR SCREWS; HOWEVER, IT IS UNKNOWN WHICH OF THE FOUR SCREWS HAS EXPLANTED. THEREFORE, THE EXPLANTED SCREW COULD BE ANY OF THE FOLLOWING: 47248604840 - BLUNT TIP SCREW, ÿ 4X48MM - 3172799, UDI: (B)(4), MANUFACTURING DATE: JUL 15, 2023, EXPIRATION DATE: JUL 15, 2028. 47248612440 - CORTICAL BONE SCREW, ÿ 4X24MM - 3160724, UDI: ((B)(4), MANUFACTURING DATE: MAY 31, 2023, EXPIRATION DATE: MAY 31, 2028. 47248612440 - CORTICAL BONE SCREW, ÿ 4X24MM - 3162266, UDI: (B)(4), MANUFACTURING DATE: JUN 8, 2023, EXPIRATION DATE: JUN 8, 2028. 47248604240 - BLUNT TIP SCREW, ÿ 4X42MM - 3158963, UDI: (B)(4), MANUFACTURING DATE: APR 15, 2025, EXPIRATION DATE: MAY 22, 2028. 47248604240 - BLUNT TIP SCREW, ÿ 4X42MM - 3152723, UDI: (B)(4), MANUFACTURING DATE: MAR 15, 2023, EXPIRATION DATE: MAR 15, 202. 47248605040 - BLUNT TIP SCREW, ÿ 4X50MM - 3158960, UDI: (B)(4), MANUFACTURING DATE: MAY 11, 2023, EXPIRATION DATE: MAY 11, 2028. D10: ITEM # 47248612440, CORTICAL BONE SCREW, ÿ 4X24MM, LOT # 3160724, ITEM # 47248612440, CORTICAL BONE SCREW, ÿ 4X24MM, LOT # 3162266, ITEM # 47248604240, BLUNT TIP SCREW, ÿ 4X42MM, LOT # 3158963, ITEM # 47248604240, BLUNT TIP SCREW, ÿ 4X42MM, LOT # 3152723, ITEM # 47248605040, BLUNT TIP SCREW, ÿ 4X50MM, LOT # 3158960, ITEM # 47249626007, PROXIMAL HUMERUS, RIGHT, LONG, ÿ 7X260MM, LOT # 3008140, ITEM # 47248801000, PROXIMAL HUMERUS NAIL CAP, 0MM, LOT # 3091392. 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, H11. 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 FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THESE ITEMS AND THE REPORTED PART AND LOT COMBINATIONS. A DEFINITIVE ROOT CAUSE COULD NOT 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 PATIENT WAS ORIGINALLY IMPLANTED WITH THE AFFIXUS HUMERAL NAIL, APPROXIMATELY 3 MONTHS POST IMPLANTATION PATIENT UNDERWENT REMOVAL OF A SCREW DUE TO UNKNOWN SYMPTOMS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483206 BLUNT TIP SCREW, ÿ 4X48MM TRAUMA, PLATE, SCREW HSB ZIMMER GMBH 3172799 00889024505483

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Hospitalization| R SEE H11 NARRATIVE.