BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUNT TIP SCREW, ÿ 4X46MM

    MDR report key: 24229172 · Received February 2, 2026

    Report

    Report Number
    0009613350-2026-00031
    Event Type
    Malfunction
    Date Received
    February 2, 2026
    Date of Event
    July 15, 2025
    Report Date
    January 30, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505476
    PMA / PMN Number
    K200814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): D10: ITEM # 47249616009, PROXIMAL HUMERUS, RIGHT, ÿ 9X160MM, LOT # 3230672, ITEM # 47248604840, BLUNT TIP SCREW, ÿ 4X48MM, LOT # 3225538, ITEM # 47248603440, BLUNT TIP SCREW, ÿ 4X34MM, LOT # 3207877, ITEM # 47248604640, BLUNT TIP SCREW, ÿ 4X46MM, LOT # 3238245, ITEM # 47248613440, CORTICAL BONE SCREW, ÿ 4X34MM, LOT # 3187130, ITEM # 47248800005, SPIDER WASHER, LOT # 3068433, ITEM # 47248800004, WASHER SMALL, LOT # 3217676. G2: FOREIGN - EVENT OCCURRED IN SPAIN. THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. THE REVIEW IDENTIFIED INTRAMEDULLARY NAIL FIXATION OF MARKEDLY COMMINUTED RIGHT PROXIMAL HUMERUS FRACTURE. THE 4- AND 6-WEEK FOLLOW-UP IMAGES SHOW LOOSENING AND BACKOUT OF 2 OF THE PROXIMAL LOCKING SCREWS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW IDENTIFIED PROXIMAL FRACTURE OF THE LEFT (CONTRALATERAL) HUMERUS, WEEKLY NON-NARCOTIC PAIN MEDICATION, NO TENDERNESS AT FRACTURE SITE, OVERALL SATISFIED. NO INSTABILITY, MODERATE PAIN 4/10, WOUND HEALED. SCREW LOOSENING, MILD, NO TREATMENT AT THIS TIME. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM A CLINICAL STUDY THAT THE PATIENT UNDERWENT AN INITIAL RIGHT PROXIMAL HUMERAL NAILING, AND SCREW LOOSENING WAS INCIDENTALLY IDENTIFIED ON RADIOGRAPHS APPROXIMATELY 6 WEEKS POST-IMPLANTATION. SUBSEQUENTLY, THE PATIENT EXPERIENCED A FALL AND SUSTAINED A FRACTURE OF THE LEFT HUMERUS; THE LEFT SIDE HAD NO IMPLANTS AND WAS MANAGED CONSERVATIVELY WITHOUT SURGICAL INTERVENTION. DURING THE NEXT FOLLOW-UP VISIT APPROXIMATELY 3 WEEKS LATER, RADIOGRAPHS SHOWED LOOSENING OF A SECOND SCREW, WHILE THE FIRST SCREW REMAINED UNCHANGED. NO ACTION WAS TAKEN AS THE PATIENT WAS NOT REPORTING PAIN OR DISCOMFORT. THE PATIENT DID NOT REQUIRE SURGICAL INTERVENTION AND REMAINED ASYMPTOMATIC. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292778 BLUNT TIP SCREW, ÿ 4X46MM TRAUMA, PLATE HSB ZIMMER GMBH 3238245 00889024505476

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female SEE H11 NARRATIVE