BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSET ACE GRATER HEAD 66MM

    MDR report key: 4802399 · Received May 28, 2015

    Report

    Report Number
    1818910-2015-22102
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    April 29, 2015
    Report Date
    April 29, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER IS COMPLAINING BLUNT AND GREY-BLACK DISCOLOURED INSTRUMENTS. THIS COMPLAINT HAS BEEN REPORTED DUE TO THE BLUNT INSTRUMENT. THE DISCOLORATION AND CORROSION ARE NOT THE REPORTABLE ISSUE. THE INVESTIGATION SUMMARIZES: ACETABULAR REAMERS (PART NUMBER 2440005XX) ARE MANUFACTURED BY SYMMETRY OTHY. THEIR INVESTIGATION WITH MANY OF THE HOSPITALS IN QUESTION INDICATE THAT THE PRELIMINARY CAUSE IS INAPPROPRIATE CLEANING COUNTER TO THE RECOMMENDATIONS IN THE INSTRUCTIONS FOR USE (IFU). THE CLEANING PROCESS AT THE HOSPITALS APPEAR TO BE CAUSING THE DAMAGE TO THE PRODUCT THROUGH SERIAL EXPOSURE TO ACIDIC AND ALKALINE SOLUTIONS WITHOUT ANY WATER RINSES, WHICH ATTACK THE PASSIVATE LAYER. THIS IS IN CONFLICT WITH THE PACKAGED IFU (IFU-0902-00-721) WHICH INDICATE TO: "PREPARE AN ENZYMATIC CLEANING SOLUTION PER THE MANUFACTURER¿S INSTRUCTIONS. SOAK SOILED INSTRUMENT FOR 5 MINUTES. USE A SOFT BRISTLE BRUSH TO REMOVE ALL TRACES OF BLOOD AND DEBRIS, PAYING CLOSE ATTENTION TO THREADS, CREVICES, SEAMS, AND ANY HARD TO REACH AREAS... RINSE THE INSTRUMENT THOROUGHLY WITH WARM TAP WATER. RINSE ALL LUMENS, INTERNAL AREAS, SLIDING MECHANISMS, AND HINGED JOINTS, ACTUATING SLIDING MECHANISMS AND HINGED JOINTS WHILE RINSING. ULTRASONICALLY CLEAN INSTRUMENT FOR 10 MINUTES IN NEUTRAL PH DETERGENT, PREPARED IN ACCORDANCE WITH THE MANUFACTURER¿S INSTRUCTIONS. RINSE THE INSTRUMENT THOROUGHLY WITH WARM TAP WATER." THE COMPLAINT WAS FOUND TO BE UNJUSTIFIED. THE ROUTE CAUSE SHALL BE ATTRIBUTED TO MISUSE AS IT WOULD APPEAR THAT THE CORRECT CLEANING INSTRUCTIONS WERE NOT FOLLOWED. NO FURTHER ACTIONS ARE IDENTIFIED. POST MARKET SURVEILLANCE IS PER (B)(4). DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    CUSTOMER IS COMPLAINING THAT THE INSTRUMENTS ARE BLUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347366 QUICKSET ACE GRATER HEAD 66MM HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. SO2010358

    Patients

    Seq Age Sex Outcome Treatment
    1