BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL HUMERUS, RIGHT, LONG, 8.5X240MM

    MDR report key: 16442292 · Received February 27, 2023

    Report

    Report Number
    0009613350-2023-00083
    Event Type
    Injury
    Date Received
    February 27, 2023
    Date of Event
    February 1, 2023
    Report Date
    May 2, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024505964
    PMA / PMN Number
    K181827
    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). D10: BLUNT TIP SCREW, 4X40MM; ITEM#47248604040; LOT#3078169. BLUNT TIP SCREW, 4X40MM; ITEM#47248604040; LOT#3082108. AFFIXUS SCREW TRAUMA IMPL WIN GEN; ITEM#UNKNOWN; LOT#UNKNOWN. TORQUE LIMITING HANDLE, A.5; ITEM#27923; LOT#UNKNOWN. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. TWO BLUNT TIP SCREWS WERE RETURNED FOR INVESTIGATION. THE OTHER PRODUCTS INVOLVED IN THE REPORTED EVENT WERE NOT RETURNED. THE TWO BLUNT TIP SCREWS WERE VISUALLY INSPECTED AND ON BOTH OF THEM IT IS POSSIBLE TO SEE THAT THE THREADED PARTS ARE PARTIALLY FLATTENED. THE HEADS OF THE BLUNT TIP SCREWS APPEAR INCONSPICUOUS. A REVIEW OF THE DEVICE MANUFACTURING RECORDS (FOR THE NAIL AND 2 BLUNT SCREWS) CONFIRMED NO ABNORMALITIES OR DEVIATIONS. THE REVIEW OF THE DEVICE MANUFACTURING RECORDS FOR THE UNKNOWN SCREW COULD NOT BE PERFORMED. DEVICES USED FOR TREATMENT. X-RAY IMAGES OF THE AFFECTED HUMERUS ARE AVAILABLE. THE X-RAYS WERE REVIEWED BY A RADIOLOGIST: TWO VIEWS OF THE RIGHT HUMERUS PROXIMALLY DEMONSTRATE AN INTRAMEDULLARY ROD WITH OBLIQUE FRACTURE LINE STILL SEEN ALONG THE PROXIMAL TO MID HUMERAL DIAPHYSIS. THREE PROXIMAL INTERLOCKING SCREWS ARE PRESENT, ALL OF WHICH APPEAR TO HAVE BACKED OUT SOMEWHAT MOST PROMINENTLY INVOLVING THE MOST PROXIMAL SCREW. NO SURGICAL REPORTS WERE PROVIDED. BASED ON THE INVESTIGATION IT COULD BE ASSUMED THAT FURTHER POSSIBLE CONTRIBUTING FACTORS TO THE MIGRATION OF THE SCREW MIGHT 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE THE ASSOCIATED REPORTS: 0009613350 - 2023 - 00086, 0009613350 - 2023 - 00089, 0009613350 - 2023 - 00198. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS:¿ BLUNT TIP SCREW, 4X40MM; ITEM#47248604040; LOT#3078169, BLUNT TIP SCREW, 4X40MM; ITEM#47248604040; LOT#3082108, TORQUE LIMITING HANDLE, A.5; ITEM#27923; LOT#UNKNOWN. 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 THE ASSOCIATED REPORTS: 0009613350 -2023 -00086, 0009613350 - 2023 -00089.

    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 THE PATIENT UNDERWENT REVISION SURGERY DUE TO MIGRATION. APPROXIMATELY ONE AND HALF MONTHS POST-OP. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800287 PROXIMAL HUMERUS, RIGHT, LONG, 8.5X240MM ROD, FIXATION, INTRAMEDULLARY HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3087021 00889024505964

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention| H