BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUNT TIP SCREW, 4X38MM

    MDR report key: 10612118 · Received October 1, 2020

    Report

    Report Number
    0009613350-2020-00441
    Event Type
    Injury
    Date Received
    October 1, 2020
    Date of Event
    September 9, 2020
    Report Date
    June 23, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024505438
    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

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DESCRIPTION: IT WAS REPORTED THAT THE PRODUCTS WERE IMPLANTED ON (B)(6), 2020. TWO WEEKS POST-IMPLANTATION THREE OF THE PROXIMAL SCREWS BACKED OUT FROM THEIR POSITION AND HENCE REVISION SURGERY WAS CONDUCTED ON (B)(6) 2020 DURING WHICH ALL IMPLANTS OF THE INITIAL SURGERY WERE EXPLANTED. REVIEW OF RECEIVED DATA: - DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. - NO MEDICAL DATA LIKE X-RAYS HAVE BEEN RECEIVED. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED FOR AN INVESTIGATION, THEREFORE NO VISUAL AND / OR DIMENSIONAL ANALYSIS COULD BE PERFORMED. REVIEW OF PRODUCT DOCUMENTATION: - DEVICE PURPOSE: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. - DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. CONCLUSION: IT WAS REPORTED THAT THE PRODUCTS WERE IMPLANTED ON (B)(6) 2020. TWO WEEKS POST-IMPLANTATION THREE OF THE PROXIMAL SCREWS BACKED OUT FROM THEIR POSITION AND HENCE REVISION SURGERY WAS CONDUCTED ON (B)(6) 2020. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, THE INVESTIGATION DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CANNOT BE CONFIRMED. NO X-RAYS HAVE BEEN RECEIVED TO ANALYZE THE IMPLANT POSITIONING AND BONE QUALITY OF THE PATIENT. BASED ON THE INVESTIGATION IT COULD BE ASSUMED THAT POSSIBLE CONTRIBUTING FACTORS TO THE MIGRATION OF THE SCREW MIGHT BE MULTIFACTORIAL RELATED TO EITHER PATIENT CONDITION AND BEHAVIOR, IMPLANTATION PROCEDURE OR DESIGN FEATURES. IF AND TO WHAT EXTENT ANY OF THESE ASPECTS MAY HAVE INFLUENCED THE BACKING OUT OF THE SCREW REMAINS UNKNOWN. IN CONCLUSION, AS THE CAUSE MAY BE MULTIFACTORIAL AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2020-00441, 0009613350-2020-00442.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. ADDITIONAL: E1, E2, E3. CORRECTION: B4, B5,G3, G6, H10. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED AGAIN. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Description of Event or Problem · 0

    FOLLOW-UP DUE TO: SURGEON¿S NAME WAS MADE AVAILABLE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: PROXIMAL HUMERUS, RIGHT, 11X160MM ITEM#47249616011; LOT#2995290; BLUNT TIP SCREW, 4X48MM; ITEM#47248604840; LOT#3006015; CORTICAL BONE SCREW, 4X24MM; ITEM; ITEM#47248612440; LOT#3010591; CORTICAL BONE SCREW, ÿ 4X24MM; ITEM; ITEM#47248612440; LOT#3010594; WASHER SMALL; ITEM#47248800004; LOT#3006467; PROXIMAL HUMERUS NAIL CAP, 0MM; ITEM#47248801000; LOT#3006469; THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE AND UNDERWENT REVISION DUE TO IMPLANT MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078438 BLUNT TIP SCREW, 4X38MM AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3010631 00889024505438

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Hospitalization| R SEE H10 NARRATIVE