BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP MOFFIT PPS-LF

    MDR report key: 11679238 · Received April 16, 2021

    Report

    Report Number
    1423395-2021-00017
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 1, 2021
    Report Date
    April 29, 2021
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    OJH
    UDI-DI
    10193489391855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL DOCUMENTATION CHANGED/ADDITIONAL INFORMATION ADDED. D9 DEVICE AVAILABLE FOR EVALUATION -N/A G6 TYPE OF REPORT - FOLLOW-UP. H2 IF FOLLOW-UP WHAT TYPE? ADDITIONAL INFORMATION. DEVICE EVALUATION. H3 DEVICE EVALUATED BY MANUFACTURER - YES, EVALUATION SUMMARY ATTACHED. H6 TYPE OF INVESTIGATION-4110, 4112, 4113, 4114. H5 INVESTIGATION CONCLUSION - DEFECT CONFIRMED: SUPPLIER MFG./ERROR ASIA (MEDLINE BRANDED). H10 INVESTIGATION REPORT READS AS FOLLOWS: INVESTIGATION SUMMARY: "04/29/2021 13:37:46 CST ((B)(6) ). "SAMPLE EVALUATION: A PHOTO WAS RECEIVED OF THE BLADE FOR OUR INVESTIGATION; THE REST OF THE PACK WAS NOT RECEIVED AT THIS TIME. UPON PHYSICAL INSPECTION OF THE RECEIVED SAMPLE, IT WAS SEEN THAT THE BLADE WAS BROKEN IN HALF, WHICH APPEARS TO BE HALF WAY ON THE CONNECTION OF THE METAL HANDLE. THERE APPEARS TO BE NO OTHER PHYSICAL DAMAGE SEEN ON THE RECEIVED DEVICE. FINISHED GOOD PRODUCTION RECORDS REVIEWED: REVIEWED THE PRODUCTION RECORDS AND NO, NON-CONFORMANCES WERE NOTED THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. FINISHED GOOD PACK BUILD REVIEWED: BOM WAS REVIEWED AND THIS COMES IN THE VENDOR PACKAGING AND IS PLACED INTO THE PREP TRAY WITH SEVERAL OTHER COMPONENTS. TRENDING: WAS REVIEWED AND THERE HAVE BEEN ZERO ADDITIONAL REPORTED COMPLAINT(S) FOR THIS ISSUE IN THE PAST 6 MONTHS. COMPONENT TRENDING: WAS REVIEWED, THERE HAVE BEEN ONE ADDITIONAL REPORTED COMPLAINT(S) FOR THIS ISSUE FOR COMPONENT 95625 THE LAST 6 MONTHS. INVESTIGATION SUMMARY: THE ACCOUNT REPORTED FINDING #10 BLADE BROKE DURING USE. THE REPORTED ISSUE OCCURRED IN ITEM DYNJ9428703M (LOT 21BKA657). BASED ON THE COMPLAINT DETAILS THE ROOT CAUSE IS CONSIDERED A VENDOR PRODUCT ISSUE RELATING TO THE COMPONENT MANUFACTURING PROCESS. ACTIONS TAKEN AND RECOMMENDATIONS: THIS COMPLAINT HAS BEEN PROVIDED TO THE COMPONENT MANUFACTURING FACILITY FOR FURTHER EVALUATION. OUR SUPPLIER QUALITY TEAM WILL ALSO MONITOR THIS ISSUE FOR TRENDING PURPOSES. "

    Description of Event or Problem · 0

    IT WAS REPORTED, "THE #10 BLADE BROKE DURING SURGERY."

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED, "THE #10 BLADE BROKE DURING SURGERY." NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. IT WAS INITIALLY REPORTED THAT NO SAMPLE IS AVAILABLE FOR RETURN AND EVALUATION THEREFORE, A ROOT CAUSE WILL BE DIFFICULT IF NOT IMPOSSIBLE TO DETERMINE. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "THE #10 BLADE BROKE DURING SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579858 HIP MOFFIT PPS-LF OJH MEDLINE INDUSTRIES, INC. 21BKA657 10193489391855

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention