BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFIXUS HUM SCREW & END CAPS

    MDR report key: 18378493 · Received December 21, 2023

    Report

    Report Number
    0009613350-2023-00708
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    December 4, 2023
    Report Date
    May 17, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505469
    PMA / PMN Number
    K181827
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4: PRODUCT ID WAS PROVIDED FOR THREE SCREWS HOWEVER, IT IS UNKNOWN WHICH OF THE THREE SCREWS HAS MIGRATED. THEREFORE, THE MIGRATED SCREW COULD BE ANY OF THE FOLLOWING: 47248604440 ¿ BLUNT TIP SCREW ¿ 3158957. UDI: (B)(4). MANUFACTURING DATE: MAY 19, 2023. EXPIRATION DATE: MAY 19, 2028. 47248604440 ¿ BLUNT TIP SCREW ¿ 3172801. UDI: (B)(4). MANUFACTURING DATE: JULY 13, 2023. EXPIRATION DATE: JULY 13, 2028. 47248604640 ¿ BLUNT TIP SCREW - 3172778. UDI: (B)(4). MANUFACTURING DATE: JULY 18, 2023. EXPIRATION DATE: JULY 18, 2028. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATIONS. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). G2: REPORT SOURCE 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 3500A WILL BE SUBMITTED. ONE OF THREE SCREWS WAS BACKED OUT BUT COULD NOT BE IDENTIFIED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2023-00704.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION APPROXIMATELY 1 WEEK POST IMPLANTATION DUE TO THE PROXIMAL SCREW WAS BACKED OUT FROM THE PROPER POSITION. 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
    2168533 AFFIXUS HUM SCREW & END CAPS TRAUMA, INSTRUMENT HSB ZIMMER GMBH N/A 3158957 00889024505469

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H 47248604440 ¿ BLUNT TIP SCREW ¿ 3172801| 47248604640 ¿ BLUNT TIP SCREW ¿ 3172778| 47249616111 ¿ ANN NAIL ¿ 3147842