BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUNT TIP SCREW, 4X36MM

    MDR report key: 17806160 · Received September 25, 2023

    Report

    Report Number
    0009613350-2023-00529
    Event Type
    Injury
    Date Received
    September 25, 2023
    Date of Event
    August 28, 2023
    Report Date
    September 25, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    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: THE FOLLOWING IMPLANTS WERE IMPLANTED DURING THE INITIAL PROCEDURE, AND IT IS UNKNOWN WHICH SCREW EXACTLY HAD BACKED OUT: ITEM#: 47-2496-200-07; LOT#: 3091682 ;ITEM NAME: PROXIMAL HUMERUS, RIGHT, LONG, 7X200MM. ITEM#: 47-2486-040-40 ;LOT#: 3091513 ;ITEM NAME: BLUNT TIP SCREW, 4X40MM. ITEM#: 47-2486-042-40 ;LOT#: 3152737 ;ITEM NAME: BLUNT TIP SCREW, 4X42MM. ITEM#: 47-2486-054-40 ;LOT#: 3091546 ;ITEM NAME: BLUNT TIP SCREW, 4X54MM. ITEM#: 47-2486-122-40 ;LOT#: 3136293 ;ITEM NAME: CORTICAL BONE SCREW, 4X22MM. ITEM#: 47-2486-124-40 ;LOT#: 3157873 ;ITEM NAME: CORTICAL BONE SCREW, 4X24MM. ITEM#: 47-2488-010-00 ;LOT#: 3158996 ;ITEM NAME: PROXIMAL HUMERUS NAIL CAP, 0MM. G2 - FOREIGN - JAPAN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE THE ASSOCIATED REPORTS: 0009613350-2023-00528. 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. 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 LOCKING MECHANISM OF THE NAIL SYSTEM 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 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 THE PATIENT UNDERWENT A REVISION SURGERY TWENTY DAYS POST A RIGHT-SIDE IMPLANTATION DUE TO PAIN AND THE FACT THAT ONE OF THE PROXIMAL SCREWS BACKED OUT FROM THE PROPER POSITION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810189 BLUNT TIP SCREW, 4X36MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3149076

    Patients

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