BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFIXUS HUM CALIB DRILL 3.3MM

    MDR report key: 20291470 · Received September 24, 2024

    Report

    Report Number
    0009613350-2024-00463
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Date of Event
    August 19, 2024
    Report Date
    January 14, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H10, H11. 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. 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. AN INTRAOPERATIVE FLUOROSCOPY IMAGE WAS PROVIDED, SHOWING THE IMPLANTED NAIL AND TWO SCREWS. A SHARP-TIPPED OBJECT IS VISIBLE NEAR THE PROXIMAL END OF THE NAIL, MOST LIKELY THE FRACTURED DRILL BIT REPORTED IN THIS EVENT. NO ISSUES WITH THE IMPLANTS ARE DETECTED BASED ON THE IMAGE PROVIDED. SINCE THIS IS AN INTRA-OP IMAGE THIS CAN ONLY PROVE THE FRACTURE OF THE DRILL BIT. BASED ON THE INFORMATION RECEIVED, THE REPORTED EVENT WAS MOST LIKELY DUE TO MISUSE DURING THE SURGERY. IT HAS BEEN CLARIFIED THAT THE ISSUE DID NOT STEM FROM A PRODUCT FAILURE OR DEFECT BUT RATHER FROM AN ERROR IN THE SURGICAL TECHNIQUE EMPLOYED. 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). D10: PROXIMAL HUMERUS, LEFT, LONG, ÿ 7X260MM ITEM #47249626107 AND LOT #3181184 G2: FOREIGN: SPAIN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    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 DURING AN INITIAL PROCEDURE A DRILL BROKE WHILE THE NAIL WAS BEING IMPLANTED, THE NAIL BROKE TOO. IT WAS REPORTED THAT THE EVENT WAS DUE TO A WRONG USE OF THE PRODUCT AND NOT DUE TO A FAILURE OF THE PRODUCTS. DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE ALL AVAILABLE ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2016971 AFFIXUS HUM CALIB DRILL 3.3MM AFFIXUS HUMERAL INSTRUMENT HSB ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11 NARRATIVE