BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINK HIP KIT

    MDR report key: 9528502 · Received December 28, 2019

    Report

    Report Number
    1643264-2019-00917
    Event Type
    Malfunction
    Date Received
    December 28, 2019
    Report Date
    February 8, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    FWZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10: H3,H6: THE DEVICE, WHICH WAS USED IN A PROCEDURE, WAS NOT RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A RELATIONSHIP, IF ANY, BETWEEN THE DEVICE AND THE REPORTED INCIDENT COULD NOT BE CONFIRMED. A DHR REVIEW WAS PERFORMED AND SHOWED NO NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LOT NUMBER PROVIDED 190816. A REVIEW OF THE COMPLAINT HISTORY RECORDS WAS PERFORMED FOR THE REPORTED LOT NUMBER 190816, THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. FACTORS THAT ARE KNOWN TO CONTRIBUTE TO THE ALLEGED FAULT/FAILURE MAY INCLUDE MISHANDLING DURING SHIPPING, USE OR REUSE OF THE DEVICE, CONTACT WITH ANOTHER SOURCE, OR WEAR AND TEAR OVER TIME. IF THE PRODUCT IS RETURNED IN THE FUTURE THE COMPLAINT CAN BE REOPENED AND EVALUATED.

    Additional Manufacturer Narrative · 0

    H10/H11: THE INITIAL INCIDENT REPORT WAS SUBMITTED WITH INCORRECT MANUFACTURING SITE INFORMATION AND REGISTRATION NUMBER 1643264 (S+N OKLAHOMA). THE CORRECT MANUFACTURING SITE INFORMATION AND REGISTRATION NUMBER IS 3003604053(S+N ANDOVER). CORRECTED DATA: D3 AND G1 MANUFACTURING SITE NAME, ADDRESS AND CONTACT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE PINK HIP KIT WAS RIPPING AND HARMING THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322940 PINK HIP KIT ACCESSORIES, OPERATING-ROOM, TABLE (KIT) FWZ SMITH & NEPHEW, INC. 190816

    Patients

    Seq Age Sex Outcome Treatment
    1