BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSET ACE GRATER HEAD 46MM

    MDR report key: 5614640 · Received April 28, 2016

    Report

    Report Number
    1818910-2016-18273
    Event Type
    Malfunction
    Date Received
    April 28, 2016
    Date of Event
    April 18, 2016
    Report Date
    April 18, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION STATUS FOR MDR: EXAMINATION OF THE RETURNED GRATER HEADS CONFIRMED THE COMPLAINT. EXAMINATION OF THE RETURNED GRATER HEAD CASE CONFIRMED THERE ARE NO ALLEGED DEFICIENCIES WITH THE CASE. 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 (B)(4). 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.

    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).

    Description of Event or Problem · 1

    THE FACILITY IS COMPLAINING ABOUT THE ACETABULAR REAMERS HAVING A DISCOLORATION ON THEM. SOME OF THE REAMERS APPEAR TO HAVE A SPECKLED LIGHT RED DISCOLORATION OVER THE SURFACE WHILE OTHERS APPEAR TO ONLY HAVE THIS DISCOLORATION AROUND THE LASER ENGRAVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269151 QUICKSET ACE GRATER HEAD 46MM HIPS INSTRUMENTS LXH DEPUY ORTHOPAEDICS, INC. 1818910 SO2020634

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR