BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® TITANIUM LARGE HEXED SCREW

    MDR report key: 8340937 · Received February 14, 2019

    Report

    Report Number
    0001038806-2019-00115
    Event Type
    Malfunction
    Date Received
    February 14, 2019
    Date of Event
    January 17, 2019
    Report Date
    May 16, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K972444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). THE CERTAIN TITANIUM LARGE HEXED SCREW (ILRGHT) WAS RECEIVED. VISUAL INSPECTION OF THE RETURNED PRODUCT IDENTIFIED THAT THE SCREW HAD FRACTURED ACROSS THE THREADS. THERE WAS SIGNIFICANT WEAR (NICKS AND GOUGES) DUE TO USAGE AROUND THE SHANK AND THE HEX FEATURE. THE FRACTURED BOTTOM PORTION WAS NOT RETURNED. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NON-CONFORMANCES WERE NOTED. LOT SPECIFIC COMPLAINT HISTORY REVIEW FOR ILRGHT (LOT #: 1212216) CONCLUDED THAT THERE ARE TWO (2) OTHER REPORTED COMPLAINTS WITH SIMILAR INCIDENT AGAINST THE SUBJECT LOTS TO DATE. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: REVIEW OF BIOMET 3I RESTORATIVE IFU (P-IIS086GR REV. E 11/2015) AND BIOMET 3I RESTORATIVE MANUAL (INSTRM REV B 10/15) IDENTIFIED INFORMATION REGARDING SCREW FRACTURE UNDER SECTION TITLE WARNINGS AND PRECAUTIONS. AS PER THE APPLICABLE IFU, IMPROPER TECHNIQUE CAN LEAD TO IMPLANT RESTORATION FRACTURE AND SCREW LOOSENING. SURGICAL MANUAL HIGHLIGHTS THE TORQUE RECOMMENDATION UNDER TORQUE MATRIX ¿ INTERNAL CONNECTION, PAGE III. COMPLAINANT REPORTED THAT THE DOCTOR CHECKED UP AND DISCOVERED THE SCREW WAS FRACTURED. THE REPORTED COMPLAINT WAS CONFIRMED THROUGH VISUAL AND PHYSICAL INSPECTION OF THE RETURNED PRODUCT. A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL PMA/510(K) NUMBER K072642.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ILRGHT SCREW WAS FRACTURED. DOCTOR WAS ABLE TO REMOVE THE FRACTURED PORTION FROM THE IMPLANT. IMPLANT IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132113 CERTAIN® TITANIUM LARGE HEXED SCREW ABUTMENT SCREW DZE BIOMET 3I 1212216

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR