BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXF UNI SILICONE ANKLE STRAP

    MDR report key: 7282135 · Received February 20, 2018

    Report

    Report Number
    3002806535-2018-00347
    Event Type
    Malfunction
    Date Received
    February 20, 2018
    Report Date
    January 21, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HRY
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PRODUCT WAS RETURNED FOR EVALUATION AND FORWARDED TO BIOMET ORTHOPEDICS LLC FOR EVALUATION, WHO HAVE REPORTED AS FOLLOWS: REVIEW OF THE RETURNED PRODUCT DETERMINED THAT THE STRAP HAS FRACTURED AS REPORTED. COMPARISON OF THE PRODUCT TO THE PRINT FOR PART 32-421429 DETERMINED THAT THE RETURNED STRAP IS NOT PART 32-421429. THERE IS NO PRODUCT IDENTIFICATION (PART OR LOT INFORMATION) ON THE RETURNED PRODUCT THEREFORE CORRECT IDENTIFICATION OF THE STRAP COULD NOT BE DETERMINED. A DEFINITIVE ROOT CAUSE OF THE STRAP FRACTURING CANNOT BE DETERMINED AND THE CONFORMANCE OF THE RETURNED PRODUCT WHEN IT LEFT ZIMMER BIOMET CONTROL CANNOT BE DETERMINED AS THE PRODUCT IDENTIFICATION IS UNKNOWN. THE PRODUCT AND LOT NUMBER IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY AND THE COMPLAINT HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 0

    (B)(4). PRODUCT NUMBERS HAVE BEEN CHECKED FOR OXFORD ANKLE STRAPS AND IT IS CONFIRMED FROM THE DRAWINGS THAT THE RETURNED PRODUCT IS 32-422778 AND NOT 32-421429 AS REPORTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Description of Event or Problem · 0

    NEW ANKLE STRAP FRACTURED DURING THE PROCEDURE.

    Description of Event or Problem · 0

    NEW ANKLE STRAP FRACTURED DURING THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). LOT NUMBER IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSION AS TO THE CAUSE OF THE EVENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    NEW ANKLE STRAP FRACTURED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126180 OXF UNI SILICONE ANKLE STRAP HRY BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other