BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERCUT METZENBAUM SCS 7 CVD

    MDR report key: 13498296 · Received February 9, 2022

    Report

    Report Number
    3014334038-2022-00015
    Event Type
    Malfunction
    Date Received
    February 9, 2022
    Date of Event
    January 12, 2022
    Report Date
    April 21, 2022
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    DWS
    UDI-DI
    10381780432517
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    METZENBAUM SCISSOR SUPERCUT, CURVED, 7¿ (102122 ) WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 0

    THE CURVED METZENBAUM SUPERCUT SCISSOR (102122) WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD (DHR) ¿ THE DHR WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. FAILURE ANALYSIS - THE INVESTIGATION OF THE UNIT CONFIRMED THE COMPLAINT: THE SCISSORS WERE IN USED CONDITION WITH THE HANDLE SNAPPED OFF DUE TO ROUGH HANDLING/ENVIRONMENTAL DAMAGE. ROOT CAUSE - THE REPORTED COMPLAINT IS CONFIRMED. THE SCISSORS WERE IN USED CONDITION WITH THE HANDLE SNAPPED OFF DUE TO ROUGH HANDLING/ENVIRONMENTAL DAMAGE. NO MANUFACTURING, WORKMANSHIP OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT THE CURVED METZENBAUM SUPERCUT SCISSOR (102122) BROKE DURING A CASE FOR KNEE ARTHROSCOPY WITH MULTIPLE LIGAMENT REPAIRS WITH ALLOGRAFTS. WHILE CUTTING SOFT TISSUE, THE SHAFT OF THE HANDLE NEAR THE LOCKBOX BROKE AND FLEW BACK, AND NEARLY HIT THE SURGEON IN THE FACE. THE STAFF IRRIGATED HEAVILY TO MAKE SURE ALL SMALL PIECES WERE REMOVED. IT WAS REPORTED THAT NO PART OF THE INSTRUMENT FELL INTO THE SURGICAL SITE THAT COULD BE SEEN WITH THE NORMAL EYE. AN X-RAY WAS PERFORMED MULTIPLE TIMES. THERE WAS A SURGICAL DELAY OF 30 MINUTES, AS THE STAFF HAD TO STOP TO ADDRESS THE ISSUE. THE NURSE OBTAINED ANOTHER PAIR OF METZENBAUM SCISSOR. IT WAS REPORTED THAT THE PATIENT'S OUTCOME WAS GREAT, ALTHOUGH PATIENT HAD TO ENDURE EXTRA MINUTES OF ANESTHESIA AND MORE DOSES OF RADIATION THAT WAS PLANNED FOR.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921732 SUPERCUT METZENBAUM SCS 7 CVD CARDIOVASCULAR SCISSORS DWS INTEGRA LIFESCIENCES MANSFIELD 100262 AA1902 10381780432517

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown