BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RASP CUX

    MDR report key: 8725689 · Received June 23, 2019

    Report

    Report Number
    1219602-2019-00737
    Event Type
    Malfunction
    Date Received
    June 23, 2019
    Date of Event
    May 20, 2019
    Report Date
    September 11, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRX
    UDI-DI
    03596010080653
    PMA / PMN Number
    K940985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 012705 CONVEX RASP INSTRUMENT WAS NOT USED FOR TREATMENT, WAS NOT RETURNED FOR EVALUATION. DUE TO PRODUCT UNAVAILABILITY, THE COMPLAINT COULD NOT BE ULTIMATELY CONFIRMED. DEFINITIVE CONCLUSIONS, ACCURATE INVESTIGATION AND EVALUATION WERE LIMITED WITHOUT EVALUATION OF PHYSICAL PRODUCT. IF OBJECTIVE EVIDENCE, RELEVANT INFORMATION, PACKAGING OR PRODUCT BECOMES AVAILABLE TO ASSIST WITH EVALUATION, THE COMPLAINT WILL CERTAINLY BE REVISITED. COMPLAINT HISTORY REVIEW FOUND NO OTHER REPORT FOR THIS LOT.

    Additional Manufacturer Narrative · 0

    ONE CUX RASP INSTRUMENT USED FOR TREATMENT, WAS RETURNED FOR EVALUATION. THIS IS A FIVE YEAR OLD REUSABLE PRODUCT OFTEN SOLD IN A SET OF THREE BONE RASP INSTRUMENTS. THE COMPLAINT STATED: ¿THE DEVICE BROKE, ALL PIECES WERE REMOVED.¿ THIS WAS CONFIRMED. THE PRODUCT WAS BROKEN. THE DISTAL RASP PADDLE TIP WAS NOT RETURNED. THE INSTRUMENT WAS FRACTURED WHERE THE RASP TIP MEETS THE SHAFT. PER INSTRUCTIONS FOR USE: ¿THESE INSTRUMENTS ARE DESIGNED FOR REPEATED USE WITH PROPER CARE AND HANDLING.¿ INSTRUMENT TIPS MAY INADVERTENTLY BE TWISTED OR CAUGHT ON OTHER INSTRUMENTS OR THE BASKET DURING CLEANING. THIS CAN LEAD TO COMPROMISED STRENGTH. AS WITH ANY SURGICAL INSTRUMENT, CAREFUL ATTENTION SHOULD BE MADE TO ASSURE THAT EXCESSIVE FORCE IS NOT PLACED ON THE INSTRUMENT. EXCESSIVE FORCES APPLIED TO THE INSTRUMENT CAN RESULT IN THE INSTRUMENT¿S 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.¿ THERE ARE NO OTHER COMPLAINTS FOR THIS LOT. THIS ALLEGATION IS CONSIDERED AN ISOLATED INCIDENT. PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION. NO ROOT CAUSE RELATED TO THE MANUFACTURING OF THIS DEVICE WAS CONFIRMED. CORRECTION IN E1:FIRST NAME: PAULA LAST NAME: RODRIGUES

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY, THE DEVICE BROKE, ALL PIECES WERE REMOVED. IT IS UNKNOWN IF THERE WAS A BACKUP DEVICE AVAILABLE TO COMPLETE THE SURGERY. DELAY OR PATIENT INJURIES WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519067 RASP CUX ARTHROSCOPE HRX SMITH & NEPHEW, INC. 15053007 03596010080653

    Patients

    Seq Age Sex Outcome Treatment
    1