BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANN PH NAIL RT 8.5X240MM

    MDR report key: 18307487 · Received December 11, 2023

    Report

    Report Number
    0009613350-2023-00687
    Event Type
    Injury
    Date Received
    December 11, 2023
    Date of Event
    October 27, 2023
    Report Date
    May 10, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505964
    PMA / PMN Number
    K200814
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN: JAPAN 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 WILL BE SUBMITTED. HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350 -2023 -00685 0009613350 -2023 -00686.

    Additional Manufacturer Narrative · 0

    (B)(4), THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. D10: 47248603840 ¿ BLUNT TIP SCREW ¿ 3136318. 47248604040 ¿ BLUNT TIP SCREW ¿ 3158948. 47248604040 ¿ BLUNT TIP SCREW - 3160705. NO PRODUCT WAS RETURNED FOR EVALUATION. THERE ARE SOME PICTURES OF SOME SCREWS AVAILABLE. THE VISUAL INSPECTION OF THE PROVIDED PICTURES SHOW THAT THE THREADED PARTS OF THE SCREWS ARE PARTIALLY FLATTENED. THE HEADS OF THE BLUNT TIP SCREWS APPEAR INCONSPICUOUS. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PRODUCTS AND ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATIONS. COMPLAINTS ARE MONITORED THROUGH MONTHLY COMPLAINT REVIEW IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. THERE ARE TWO X-RAY IMAGES AVAILABLE. THE REVIEW WAS DONE BY A RADIOLOGIST. TWO VIEWS OF THE RIGHT HUMERUS DEMONSTRATE A RECENTLY PLACED RIGHT HUMERAL INTRA-MEDULLARY ROD WITH THREE PROXIMAL SCREWS. OF THESE THREE PROXIMAL SCREWS, THE MIDDLE AND DISTAL SCREWS HAVE BACKED OUT. OBLIQUE FRACTURE ALONG THE MID HUMERAL DIAPHYSIS. NO DISLOCATION. SURGICAL SKIN STAPLES. IT CAN BE ASSUMED THAT MULTIPLE CONTRIBUTING FACTORS, RELATED TO EITHER PATIENT CONDITION AND BEHAVIOR OR IMPLANTATION PROCEDURE, CONTRIBUTED TO THE MIGRATION OF THE SCREWS. IF AND TO WHAT EXTENT ANY OF THESE ASPECTS MAY HAVE INFLUENCED THE MIGRATION OF THE SCREW REMAINS UNKNOWN. AN ADDITIONAL DEEPER INVESTIGATION WAS PERFORMED WHICH IDENTIFIED THE DESIGN LIMITATION OF THE CORELOCK MECHANISM OF THE AFFIXUS NAIL AS A POTENTIAL CONTRIBUTING FACTOR. AS PART OF THE DEEPER INVESTIGATION, A SCIENTIFIC LITERATURE SEARCH WAS CONDUCTED AND A SYSTEMATIC REVIEW OF THE OUTCOME OF INTRAMEDULLARY NAILING FOR ACUTE PROXIMAL HUMERUS FRACTURE SHOWED THAT SCREW MIGRATION AND PERFORATION INTO THE JOINT IS THE SECOND MOST COMMON COMPLICATION FOLLOWING SECONDARY LOSS OF REDUCTION. IN ADDITION, SCIENTIFIC LITERATURE OF COMPETITOR AND PREDICATE DEVICES WERE ASSESSED. THIS REVIEW HAS SHOWN THAT THE AFFIXUS® NATURAL NAIL® PROXIMAL HUMERAL SYSTEM PERFORMS BETTER AND/OR IN EQUAL RANGE IN COMPARISON WITH LEGALLY MARKETED SIMILAR DEVICES. IN CONCLUSION, AS THE CAUSE MAY BE MULTIFACTORIAL AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE MIGRATION OF THE SCREW. 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 A REVISION SURGERY DUE TO PROXIMAL SCREWS WERE BACKED OUT FROM THE PROPER POSITION, APPROXIMATELY ONE (1) MONTH AFTER IMPLANTATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1110982 ANN PH NAIL RT 8.5X240MM HIP IMPLANT HSB ZIMMER GMBH N/A 3152739 00889024505964

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H