BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSET ACE GRATER HEAD 45MM

    MDR report key: 5356272 · Received January 9, 2016

    Report

    Report Number
    1818910-2016-10378
    Event Type
    Malfunction
    Date Received
    January 9, 2016
    Date of Event
    December 16, 2015
    Report Date
    January 29, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT REMAINS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED INSTRUMENTS CONFIRMED THE COMPLAINT. SEVERAL INSTRUMENTS WERE NOT RETURNED FOR EVALUATION. A PREVIOUS SUPPLIER'S INVESTIGATION WITH MANY HOSPITALS INDICATES THE ROOT CAUSE IS ATTRIBUTED TO 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 INDICATES 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 COMPLETE INVESTIGATION OF RUSTING/CORROSION IS DOCUMENTED WITHIN DR-003347. NO FURTHER ACTIONS INDICATED. COMPLAINTS WILL BE MONITORED UNDER POST MARKET SURVEILLANCE SEP 419. DEPUY 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. 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.

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    CUSTOMER IS COMPLAINING RUST ON THE INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15024 QUICKSET ACE GRATER HEAD 45MM HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. SO2019784

    Patients

    Seq Age Sex Outcome Treatment
    1