BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3MMX1000MM BALL TP GDE RD

    MDR report key: 16554310 · Received March 16, 2023

    Report

    Report Number
    1020279-2023-00553
    Event Type
    Malfunction
    Date Received
    March 16, 2023
    Date of Event
    February 16, 2023
    Report Date
    April 12, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRS
    UDI-DI
    03596010529107
    PMA / PMN Number
    K123055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: CASE(B)(4).

    Additional Manufacturer Narrative · 0

    H3, H6. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. A REVIEW OF THE PRODUCTION ORDER DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF COMPLAINT HISTORY FOR THE PART NUMBER OVER THE PAST 12 MONTHS AND FOR THE BATCH NUMBER BASED ON HISTORICAL DATA OF THE DEVICE DID NOT REVEAL SIMILAR EVENTS FOR THE LISTED DEVICE. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. A HISTORICAL REVIEW CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS PRODUCT AND EVENT. MATERIAL SPECIFICATION, COVERS THE REQUIREMENTS FOR A PREFORMED POUCH CONSISTING OF HEAT SEAL COATED DUPONT 1073B TYVEK HEAT SEALED TO POLYETHYLENE/POLYESTER FILM, TO PRODUCE A STERILE BARRIER PACKAGING ASSEMBLY FOR THE PACKAGING OF STERILE MEDICAL PRODUCTS. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT INCLUDE DAMAGE DURING SHIPPING AND/OR MISHANDLING. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING THE SET UP AND INSPECTION FOR AN UNKNOWN SURGERY, IT WAS NOTICED THAT THE PACKAGE OF A 3MMX1000MM BALL TP GDE RD WAS NOT FEELING SEALED WHEN OPENED. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO PATIENT INJURIES OR SURGERY DELAYS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437454 3MMX1000MM BALL TP GDE RD PLATE, FIXATION, BONE HRS SMITH & NEPHEW, INC. 71631626 21LNX0001 03596010529107

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown