BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANN, BLUNT TIP SCREW, 4X42MM

    MDR report key: 14433097 · Received May 18, 2022

    Report

    Report Number
    0009613350-2022-00283
    Event Type
    Injury
    Date Received
    May 18, 2022
    Date of Event
    April 20, 2022
    Report Date
    July 26, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505452
    PMA / PMN Number
    K181827
    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). CONCOMITANT MEDICAL DEVICES: ANN, PROXIMAL HUMERUS, RIGHT, 7X160MM; ITEM# 47249616007; LOT# 3091683. BLUNT TIP SCREW, 4X42MM; ITEM# 47248604240; LOT# 3076740. BLUNT TIP SCREW, 4X44MM; ITEM# 47248604440;LOT# 3076741. CORTICAL BONE SCREW, 4X30MM; ITEM# 47248613040, LOT# 3073753. CORTICAL BONE SCREW, 4X32MM; ITEM# 47248613240, LOT# 3068973. PROXIMAL HUMERUS NAIL CAP, 10.5X2.5MM; ITEM# 47248801002; LOT# 3068978. REPORT SOURCE ¿ FOREIGN ¿ (B)(6). NO PRODUCT RETURN. PRODUCT REMAINS IMPLANTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2022-00282, 0009613350-2022-00284, 0009613350-2022-00286. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING THAT COULD BE RELATED TO THE REPORTED EVENT. 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. A DEEPER INVESTIGATION WAS PERFORMED WHICH IDENTIFIED THE DESIGN LIMITATION OF THE CORELOCK MECHANISM AS A POTENTIAL CONTRIBUTING FACTOR AS WELL. HOWEVER, FURTHER BIOMECHANICAL TESTING WAS CARRIED OUT AND AS THE PRODUCT PERFORMANCE IS IN AN ACCEPTABLE RANGE IN COMPARISON WITH LEGALLY MARKETED SIMILAR DEVICES, NO DESIGN CHANGES WERE CONDUCTED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE OF THE PROXIMAL SCREWS BACKED OUT FROM THE PROPER POSITION ONE WEEK AFTER INITIAL IMPLANTATION. THE SURGEON IS KEEPING AN EYE ON THE PATIENT'S CONDITION. NO REVISION SURGERY PLANNED SO FAR. NO HARM REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1975771 ANN, BLUNT TIP SCREW, 4X42MM ROD, FIXATION HSB ZIMMER SWITZERLAND MANUFACTURER GMBH N/A 3073795 00889024505452

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other SEE H10 NARRATIVE.