BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUNT TIP SCREW, ÿ 4X36MM

    MDR report key: 18924483 · Received March 18, 2024

    Report

    Report Number
    0009613350-2024-00075
    Event Type
    Injury
    Date Received
    March 18, 2024
    Date of Event
    February 21, 2024
    Report Date
    March 18, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505421
    PMA / PMN Number
    K200814
    Removal / Correction Number
    N/A
    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, ÿ 4X52MM ITEM# 47248605240 LOT# 3086989. BLUNT TIP SCREW, ÿ 4X42MM ITEM# 47248604240 LOT# 3142306. BLUNT TIP SCREW, ÿ 4X36MM ITEM# 47248603640 LOT# 3091449. HUMERUS BALL NOSE GUIDEWIRE, STERILE ITEM# 110035668 LOT# 3148972. CORTICAL BONE SCREW, ÿ 4X26MM ITEM# 47248612640 LOT# 3139153. PROXIMAL HUMERUS NAIL CAP, ÿ 11X2.5MM ITEM# 47248801102 LOT# 3010713. PROXIMAL HUMERUS NAIL CAP, ÿ 11X5MM ITEM# 47248801105 LOT#3054474. G2. REPORT SOURCE: JAPAN. 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. REVIEW OF COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PRODUCTS AND ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATIONS. COMPLAINTS ARE MONITORED THROUGH MONTHLY COMPLAINT REVIEW IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. 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: 0009613350-2024-00074.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN NAIL, AFTER 8 MONTHS FROM THE INITIAL, SURGEON FOUND #1 PROXIMAL SCREW WAS BACKED OUT FROM THE PROPER POSITION. THE PATIENT COMPLAINED OF PAIN AND A REVISION SURGERY WAS PERFORMED TO REMOVE THE MIGRATED SCREW. 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
    2556303 BLUNT TIP SCREW, ÿ 4X36MM PROSTHESIS, HIP HSB ZIMMER GMBH N/A 3091446 00889024505421

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Required Intervention| H SEE H10 NARRATIVE