BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANN BLUNT TIP SCREW

    MDR report key: 18112500 · Received November 10, 2023

    Report

    Report Number
    0009613350-2023-00610
    Event Type
    Malfunction
    Date Received
    November 10, 2023
    Date of Event
    October 10, 2023
    Report Date
    January 12, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4: IT IS UNKNOWN WHICH BLUNT TIP SCREW HAS MIGRATED: 47-2486-048-40 - ANN BLUNT TIP SCREW 4X48MM 3082034; 47-2486-050-40 - ANN BLUNT TIP SCREW 4X50MM 3082035; 47-2486-050-40 - ANN BLUNT TIP SCREW 4X50MM 3091597. D10. 47-2486-126-40 - ANN CORT BONE SCREW 4 X 26MM 3155791; 47-2486-130-40 - ANN CORT BONE SCREW 4 X 30MM 3149095; 47-2488-010-00 - AFFIXUS PH NL CAP 0MM 3158962; 47-2496-160-09 - ANN PH NAIL RT 9X160MM 3141969; 47249616009 - PROXIMAL HUMERUS, RIGHT, ÿ 9X160MM 3141969. G.2 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350 - 2023 - 00620

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G3, H2, H3, H6. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED, AS THE PRODUCTS REMAIN IMPLANTED; VISUAL AND DIMENSIONAL EVALUATIONS COULD THEREFORE NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. DEVICES ARE USED FOR TREATMENT. REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS 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. TWO UNDATED AP RADIOGRAPHIC IMAGES OF THE RIGHT SHOULDER WERE PROVIDED AND REVIEWED BY A RADIOLOGIST WITH THE FOLLOWING ASSESSMENT: THERE IS A COMMINUTED FRACTURE OF THE HUMERAL NECK WITH INTRAMEDULLARY NAIL AND SCREW FIXATION. THERE IS NO HARDWARE FRACTURE. ON ONE OF THE IMAGES, A SINGLE PROXIMAL SCREW IS MARKEDLY RETRACTED WHEN COMPARED TO THE OTHER IMAGE. ALIGNMENT OF THE FRACTURE IS UNCHANGED. THE FRACTURE IS NOT YET HEALED. BONE QUALITY IS OSTEOPENIC. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2023-00620-1.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN NAIL AFTER 6 WEEKS FROM THE INITIAL, SURGEON FOUND #3 PROXIMAL SCREW WAS BACKED OUT FROM THE PROPER POSITION. NO REVISION SURGERY WILL BE PLANNED SO FAR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION. DILIGENCE IS COMPLETED AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1832468 ANN BLUNT TIP SCREW PROSTHESIS, TRAUMA HSB ZIMMER GMBH N/A SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SEE H10.