BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC CANN DRILL BIT 10MM

    MDR report key: 8520396 · Received April 16, 2019

    Report

    Report Number
    1219602-2019-00434
    Event Type
    Malfunction
    Date Received
    April 16, 2019
    Date of Event
    March 28, 2019
    Report Date
    June 18, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWE
    UDI-DI
    03596010025203
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 013663 CANNULATED ENDOSCOPIC 10MM DRILL BIT REPORTED ON. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. PHYSICAL CONCLUSIONS, FULL INVESTIGATION AND EVALUATION WERE RESTRICTED. FACTORS AFFECTING DEVICE PERFORMANCE INCLUDE: DEVICE ABILITY, SURGICAL ABILITY AND SURGICAL SITE PREPARATION ACCORDING TO INSTRUCTIONS FOR USE. CONFIRMS INSTRUCTIONS, PRECAUTIONARY STATEMENTS AND RECOMMENDATIONS FOR PROPER USE OF PRODUCT. ¿THESE INSTRUMENTS ARE DESIGNED FOR REPEATED USE WITH PROPER CARE AND HANDLING.¿ PLEASE REFER TO FOR INSTRUCTIONS ON AUTOMATIC AND MANUAL STERILIZATION RECOMMENDATIONS. LOW-SUDSING, NEUTRAL 6.0¿8.0 PH, ENZYMATIC DETERGENTS ARE RECOMMENDED. DO NOT USE DETERGENTS ABOVE 11.0 PH. USE DEIONIZED WATER FOR WASHING AND RINSING. THERE ARE NO OTHER COMPLAINTS FOR THIS LOT. THIS IS CONSIDERED AN ISOLATED INSTANCE. ALLEGATION OCCURRENCE RATE IS MONITORED VIA SURVEILLANCE. FURTHER ACTION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED A RUST ON THE DRILL BIT. NO PATIENT INJURIES OR DELAY WERE REPORTED AS THE FAILURE WAS FOUND AFTER THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310233 ENDOSCOPIC CANN DRILL BIT 10MM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE SMITH & NEPHEW, INC. VSW62257/1 03596010025203

    Patients

    Seq Age Sex Outcome Treatment
    1