BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCH BSKT SCP UPSWPT 1.3MM

    MDR report key: 8542047 · Received April 23, 2019

    Report

    Report Number
    1219602-2019-00458
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Date of Event
    April 17, 2019
    Report Date
    August 28, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NBH
    UDI-DI
    03596010023599
    PMA / PMN Number
    D164484
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 012031 1.3MM UPSEWPT SCOOP PUNCH BASKET INSTRUMENT USED FOR TREATMENT, WAS RETURNED FOR EVALUATION. THIS IS A TWO YEAR OLD REUSABLE INSTRUMENT. FUNCTIONAL TEST WAS NOT POSSIBLE AS THE PRODUCT ARRIVED DISASSEMBLED AND NOT ALL PIECES WERE RETURNED. THE SCISSOR HANDLE SECTION IS INTACT. THE FRONT END ASSEMBLY IS IN PIECES AND THE ARTICULATING JAW COMPONENT WAS ABSENT. THE ACTUATOR HAS HAD WORK DONE TO IT AND IS ALSO DAMAGED IN THE TIP AREA. THE LOWER BASKET COMPONENT CUTTING EDGE HAS DULL AND WAVY EDGES. THE CONDITION IS ALIGNED WITH THE DISTAL TIP BEING USED FOR LEVERAGE, BEING TWISTED OR PULLED. NO ROOT CAUSE RELATED TO THE MANUFACTURING OF THIS DEVICE WAS CONFIRMED.

    Additional Manufacturer Narrative · 0

    ONE 012031 UPSWEPT SCOOP PUNCH BASKET INSTRUMENT REPORTED ON. DUE TO UNAVAILABILITY OF THE DEVICE, DEFINITIVE CONCLUSIONS, ACCURATE INVESTIGATION AND EVALUATION WERE LIMITED WITHOUT PHYSICAL EVALUATION. IF OBJECTIVE EVIDENCE BECOMES AVAILABLE TO ASSIST WITH EVALUATION, THE COMPLAINT WILL BE REVISITED. PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. EVENT DESCRIPTION UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE BROKE DURING SURGERY. NO DELAY REPORTED. A BACK-UP DEVICE WAS AVAILABLE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BROKE DURING SURGERY. IT IS UNKNOWN IF THERE WAS DELAY IN THE PROCEDURE. A BACK-UP DEVICE WAS AVAILABLE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335510 PCH BSKT SCP UPSWPT 1.3MM ACCESSORIES,ARTHROSCOPIC NBH SMITH & NEPHEW, INC. 50638336 03596010023599

    Patients

    Seq Age Sex Outcome Treatment
    1