BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNCH DUCKLING UPSWEPT W/PRO HNDL

    MDR report key: 10477839 · Received September 1, 2020

    Report

    Report Number
    1219602-2020-01340
    Event Type
    Malfunction
    Date Received
    September 1, 2020
    Date of Event
    August 10, 2020
    Report Date
    September 2, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NBH
    UDI-DI
    03596010473912
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10, H3,H6: 7207672 ACUFEX PRO UPSWEPT DUCKLING BASKET PUNCH USED INTENDED FOR USE IN TREATMENT WAS RETURNED FOR EVALUATION. THIS IS A TWO YEAR OLD REUSABLE INSTRUMENT. THERE ARE LIGHT AND TYPICAL SURFACE SCRATCHES FROM USES AND CONTACT WITH OTHER INSTRUMENTS. THE ACTUATOR HAS BECOME DISENGAGED. THE UPPER ARTICULATING JAW COMPONENT REMAINS CLOSED REGARDLESS OF SCISSOR HANDLE POSITION; OPEN OR CLOSED. THERE WERE LIGHT DINGS NOTED ALONG THE EDGE OF THE JAW ALTHOUGH WITH MANUAL OPENING IT STILL TOOK A CRISP SNIP OF SAMPLE MATERIAL. THE SYMPTOMS WERE ALIGNED WITH EXCESS TWISTING, PULLING, GRASPING OR LIFTING OF TISSUE AND BONE. IT HAS ALSO BEEN FOUND TO BE CONSISTENT WITH LONG TERM USE OR UNINTENTIONAL ENTANGLED WITH OTHER INSTRUMENTS OR DEVICES WHILE LOADED INTO BASKETS FOR STERILIZATION. PER IFU 1060355: ¿PRIOR TO USE, INSPECT THE DEVICE TO ENSURE IT IS NOT DAMAGED. DO NOT USE A DAMAGED DEVICE. THESE INSTRUMENTS ARE DESIGNED FOR REPEATED USE WITH PROPER CARE AND HANDLING. AS WITH ANY SURGICAL INSTRUMENT, CAREFUL ATTENTION SHOULD BE EXERCISED TO ENSURE THAT EXCESSIVE FORCE IS NOT PLACED ON THE INSTRUMENT. EXCESSIVE FORCE CAN RESULT IN INSTRUMENT FAILURE. DO NOT USE THESE INSTRUMENTS AS LEVERS FOR MANIPULATING HARD TISSUE OR BONE. EXCESSIVE FORCE SHOULD NOT BE APPLIED TO THE INSTRUMENT WHEN MANIPULATING SOFT TISSUE, BONE, OR HARD OBJECTS. MISUSE OF THESE INSTRUMENTS MAY RESULT IN BENT DISTAL TIPS OR JAWS; AND DULL OR UNEVEN CUTTING EDGES.¿ COMPLAINT HISTORY REVIEW INDICATED NO SIMILAR ALLEGATIONS FOR THE LOT NUMBER REPORTED. BATCH REVIEW DID NOT INDICATE A CONDITION, PRODUCT OR PROCEDURE FAILURE THAT SUPPORTED THE ALLEGATION. INSTRUCTIONS FOR USE (IFU) CONTAINS RECOMMENDATIONS AND PRECAUTIONARY STATEMENTS FOR PROPER USE OF PRODUCT. PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DUCKLING DEVICE BROKE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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
    944134 PNCH DUCKLING UPSWEPT W/PRO HNDL ACCESSORIES,ARTHROSCOPIC NBH SMITH & NEPHEW, INC. 7207672 50704311 03596010473912

    Patients

    Seq Age Sex Outcome Treatment
    1