BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUNT TIP SCREW, ÿ 4X46MM

    MDR report key: 23497512 · Received November 7, 2025

    Report

    Report Number
    0009613350-2025-00868
    Event Type
    Injury
    Date Received
    November 7, 2025
    Date of Event
    October 23, 2025
    Report Date
    April 21, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505476
    PMA / PMN Number
    K231114
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: PROXIMAL HUMERUS, LEFT, #ITEM 47249616107, #LOT 3163113 PROXIMAL HUMERUS NAIL CAP, #ITEM 47248801000, #LOT 3208165 BLUNT TIP SCREW, #ITEM 47248604840, #LOT 3205625 BLUNT TIP SCREW, #ITEM 47248604440, #LOT 3202505 CORTICAL BONE SCREW, #ITEM 47248613040, #LOT 3197007 CORTICAL BONE SCREW, #ITEM 47248613240, #LOT 3183248 THERAPY DATE: (B)(6) 2025 G2: COUNTRY REPORT SOURCE: SPAIN. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D2, G1, G3, G6, H1, H2, H3, H6. THE CMP WAS CONFIRMED. 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. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THE NAIL ITEM AND THE REPORTED PART AND LOT COMBINATION. REVIEW OF THE COMPLAINT HISTORIES FOR THE SCREWS AND CAP 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. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW IDENTIFIED THAT PATIENT HAD AN INITIAL RIGHT ALPS CLAVICLE SYSTEM IMPLANTED. SUBSEQUENTLY, THE PATIENT EXPERIENCED A ROTATOR CUFF WITH FAILED REPAIRMENT 1 YEAR LATER. PATIENT REPORTED PAIN AND STIFFNESS. THE DELTOID INSERTION WAS PAINFUL. THE RADIOGRAPHS SHOWED NO DISPLACEMENT. FRACTURE WAS CONSOLIDATED IN GOOD POSITION. THE NAIL PROTRUDES NEXT TO A SCREW. PATIENT WAS TRANSFERED TO EMERGENCY AFTER FALLING ON THE GROUND. NAIL, CAP AND SCREWS WERE REMOVED. REVIEW OF MEDICAL RECORDS IDENTIFIED SEIZURE WITH FALL AS CONTRIBUTING FACTOR TO THE EVENT. 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 THAT AN INITIAL CLAVICLE PLATING FOR FRACTURE COMPLETED. THE PATIENT REPORTED PERSISTENT PAIN AND STIFFNESS AFTER SURGERY AT AROUND 9 MONTHS POST-OP AND THE FRACTURE WAS OBSERVED TO BE CONSOLIDATED IN GOOD POSITION SO DEVICE REMOVAL WAS RECOMMENDED. ON IMAGING NAIL PROTRUSION WAS NOTED. THE DEVICE REMOVAL PROCEDURE WAS COMPLETED ON ONE YEAR POST IMPLANTATION WITHOUT ANY KNOWN COMPLICATIONS. FURTHER DETAILS HAVE NOT BEEN PROVIDED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630393 BLUNT TIP SCREW, ÿ 4X46MM IMPLANT, TRAUMA HSB ZIMMER GMBH 3207879 00889024505476

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Hospitalization| R SEE H11 NARRATIVE.