BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUNT TIP SCREW, 4X40MM

    MDR report key: 17264837 · Received July 6, 2023

    Report

    Report Number
    0009613350-2023-00367
    Event Type
    Injury
    Date Received
    July 6, 2023
    Date of Event
    June 5, 2023
    Report Date
    July 26, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    PMA / PMN Number
    K181827
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 ¿ ASSOCIATED PRODUCTS: ITEM #47-2486-034-40 ITEM NAME #BLUNT TIP SCREW, 4X34MM LOT #3006501, ITEM #47-2486-040-40 ITEM NAME #BLUNT TIP SCREW, 4X40MM LOT #2999928, ITEM #47-2496-240-07 ITEM NAME #PROXIMAL HUMERUS, RIGHT, LONG, 7X240MM LOT #3033165, ITEM #110035651 ITEM NAME #HUMERUS CALIBRATED DRILL, 3.3MM, STERILE LOT #3026085, ITEM #110035668 ITEM NAME #HUMERUS BALL NOSE GUIDEWIRE, STERILE, LOT #3056510, ITEM #47-2486-126-40 ITEM NAME #CORTICAL BONE SCREW, 4X26MM LOT #3091273, ITEM #47-2486-136-40 ITEM NAME #CORTICAL BONE SCREW, 4X36MM LOT #3024634, AND ITEM #47-2486-124-40 ITEM NAME #CORTICAL BONE SCREW, 4X24MM LOT #3054270. G2 ¿ FOREIGN ¿ AUSTRALIA. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2023-00368, 0009613350-2023-00367, AND 0009613350-2023-00370. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 COULD BE RELATED TO THE REPORTED EVENT. DEVICES ARE USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. 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, ASCIENTIFIC 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 THESECOND 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2023-00368. 0009613350-2023-00370. 0009613350-2023-00417. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCREWS HAVE STARTED TO BACK OUT OF THE NAIL APPROXIMATELY TWO (2) MONTHS POST IMPLANTATION. NO CONSEQUENCES OR IMPACT TO THE PATIENT. 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
    990963 BLUNT TIP SCREW, 4X40MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3054465

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Other