BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUNT TIP SCREW, ÿ 4X34MM

    MDR report key: 22169774 · Received June 9, 2025

    Report

    Report Number
    0009613350-2025-00408
    Event Type
    Injury
    Date Received
    June 9, 2025
    Date of Event
    May 17, 2024
    Report Date
    October 28, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505414
    PMA / PMN Number
    K200814
    Adverse Event
    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, LONG, ÿ 7X220MM ITEM# 47249622107 LOT# 3127391 BLUNT TIP SCREW, ÿ 4X34MM ITEM# 47248603440 LOT# 3091447. CORTICAL BONE SCREW, ÿ 4X20MM ITEM# 47248612040, LOT# 3126149. CORTICAL BONE SCREW, ÿ 4X22MM ITEM# 47248612240, LOT# 3152713. PROXIMAL HUMERUS NAIL CAP, 0MM ITEM# 47248801000, LOT# 3151018. G2. REPORT SOURCE: SPAIN. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: A3, B3, B4, B5, B7, D6B, G3, G6, H2, H6, H10, H11.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A4; B5; D2A; D8; E1; G3; G6; H2; H3; H6; H10; H11 THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS. RADIOGRAPHIC IMAGING WAS REVIEWED BY A RADIOLOGIST AND INCLUDED A SINGLE INTRAOPERATIVE FLUOROSCOPIC IMAGE ALONG WITH TWO FOLLOW-UP STUDIES FEATURING ANTEROPOSTERIOR (AP) AND SCAPULAR Y VIEWS OF THE LEFT HUMERUS. RADIOGRAPHIC REVIEW SHOWED THE INTRAMEDULLARY NAIL POSITIONED PROUD OF THE HUMERAL ARTICULAR SURFACE, WITH THIS ALIGNMENT UNCHANGED DURING FOLLOW-UP. PROGRESSIVE BACK-OUT OF THE PROXIMAL INTERLOCKING SCREW WAS OBSERVED, WHICH MAY HAVE CONTRIBUTED TO SOFT TISSUE IRRITATION OR IMPINGEMENT. NO DIRECT HARDWARE-RELATED COMPLICATIONS WERE DOCUMENTED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE HAS BEEN IDENTIFIED AS AN INITIAL INCORRECT ALIGNMENT OF THE NAIL RELATIVE TO HUMERUS. 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 THAT THE PATIENT HAD AN INITIAL PROCEDURE WITH AFFIXUS HUMERAL NAIL SYSTEM. SUBSEQUENTLY, EXPERIENCED NAIL PROTRUSION WITH IMPINGEMENT SYMPTOMS AND APPROXIMATELY ONE YEAR POST IMPLANTATION UNDERWENT A REVISION SURGERY WHEN THE DEVICE WAS REMOVED. DUE DILIGENCE IS IN PROCESS AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD AN INITIAL ORIF OF THE LEFT HUMERUS. SUBSEQUENTLY, THE SITE REPORTED NAIL PROTRUSION WITH IMPINGEMENT SYMPTOMS. THE PATIENT UNDERWENT HARDWARE REMOVAL, APPROXIMATELY 10 MONTHS POST IMPLANTATION, WITH REPAIR OF A PARTIAL ROTATOR CUFF INJURY. NO COMPLICATIONS OR ALLEGATIONS AGAINST HARDWARE WERE REPORTED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A CLINICAL STUDY THAT THE PATIENT UNDERWENT AN INITIAL OPEN REDUCTION AND INTERNAL FIXATION OF THE LEFT HUMERUS ON AN UNKNOWN DATE WITH IMPLANTATION OF A HUMERAL NAIL. APPROXIMATELY 3 MONTHS POST-IMPLANTATION, THE SITE REPORTED NAIL PROTRUSION WITH IMPINGEMENT SYMPTOMS. THE PATIENT SUBSEQUENTLY UNDERWENT COMPLETE HARDWARE REMOVAL APPROXIMATELY 10 MONTHS POST-IMPLANTATION. AT THE TIME OF REMOVAL, A PARTIAL ROTATOR CUFF INJURY WAS REPAIRED. THE EVENT WAS CLASSIFIED BY THE SITE AS A SERIOUS ADVERSE EVENT AND ASSESSED AS NOT RELATED TO THE DEVICE OR INSTRUMENTS, WITH CAUSALITY ATTRIBUTED TO THE SURGICAL PROCEDURE. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. NO COMPLICATIONS OR ALLEGATIONS AGAINST THE HARDWARE WERE REPORTED. THE PATIENT WAS REPORTED AS IMPROVED/RECUPERATED APPROXIMATELY 6 WEEKS AFTER HARDWARE REMOVAL. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320339 BLUNT TIP SCREW, ÿ 4X34MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ZIMMER GMBH 3091296 00889024505414

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention| H SEE H11 NARRATIVE.