BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUNT TIP SCREW, 4X36MM

    MDR report key: 16485420 · Received March 6, 2023

    Report

    Report Number
    0009613350-2023-00105
    Event Type
    Injury
    Date Received
    March 6, 2023
    Date of Event
    February 7, 2023
    Report Date
    April 3, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024505421
    PMA / PMN Number
    K200814
    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). CONCOMITANT MEDICAL PRODUCTS: PROXIMAL HUMERUS, LEFT, 9X160MM; ITEM#: 47249616109; LOT#: 3083195; BLUNT TIP SCREW; 4X36MM; ITEM#: 47248603640; LOT#: 3091267; BLUNT TIP SCREW; 4X40MM; ITEM#: 47248604040; LOT#: 3078228; TORQUE LIMITING HANDLE; A.5; ITEM#: 27923; LOT#: UNKNOWN. 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 - 00103, 0009613350 - 2023 - 00104, 0009613350 - 2023 - 00105, AND 0009613350 - 2023 - 00106.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, G6, H2, H3, H6, H10. 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 THAT MIGHT BE RELATED TO THE REPORTED EVENT. DEVICES USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. BASED ON THE INVESTIGATION, IT COULD CAN BE ASSUMED THAT POSSIBLE CONTRIBUTING FACTORS CONTRIBUTING TO THE MIGRATION OF THE SCREWS MIGHT COULD BE MULTIFACTORIAL RELATED TO EITHER PATIENT CONDITION, BEHAVIOR OR IMPLANTATION PROCEDURE. 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 THREE MONTHS POST-IMPLANTATION, THE SURGEON FOUND THAT THE TWO PROXIMAL SCREWS WERE BACKED OUT FROM THE PROPER POSITION. THE SURGEON WILL CONTINUE TO MONITOR THE PATIENT'S CONDITION. REVISION SURGERY IS NOT CURRENTLY PLANNED. 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 FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531466 BLUNT TIP SCREW, 4X36MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3091297 00889024505421

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Other SEE H10 NARRATIVE