BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBINATION REAMER ASSEMBLY OMEGA STANDARD

    MDR report key: 3924587 · Received July 10, 2014

    Report

    Report Number
    0008031020-2014-00299
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    STRYKER GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED INCIDENT THAT COMBINATION REAMER ASSEMBLY OMEGA STANDARD WAS ALLEGED OF ISSUE S-67 (CONTAMINATION OF THE DEVICE) COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE FAILURE WAS CAUSED BY INADEQUATE CLEANING / STERILIZATION, AS IT WAS MENTIONED THAT THE PROBLEM WAS FOUND DURING OPENING THE OMEGA PIN AND PLATE SET. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. PLEASE SEE AS NOTED BELOW; THE CLEANING AND STERILIZATION GUIDE (L24002000-EN REV. N_OT-RG-1_REV-2_ CLEANING & STERILIZATION GUIDE_2015-8332): ''BEFORE PREPARING FOR STERILIZATION, ALL MEDICAL DEVICES SHOULD BE INSPECTED. GENERALLY UN-MAGNIFIED VISUAL INSPECTION UNDER GOOD LIGHT CONDITIONS IS SUFFICIENT. ALL PARTS OF THE DEVICES SHOULD BE CHECKED FOR VISIBLE SOIL AND/ OR CORROSION. PARTICULAR ATTENTION SHOULD BE PAID TO: SOIL "TRAPS" SUCH AS MATING SURFACES, HINGES, SHAFTS OF FLEXIBLE REAMERS. RECESSED FEATURES (HOLES, CANNULATIONS). FEATURES WHERE SOIL MAY BE PRESSED INTO CONTACT WITH THE DEVICE, E.G. DRILL FLUTES ADJACENT TO THE CUTTING TIP, SIDES OF TEETH ON BROACHES AND RASPS. CUTTING EDGES SHOULD BE CHECKED FOR SHARPNESS AND DAMAGE. FOR DEVICES THAT MAY BE IMPACTED CHECK THAT THE DEVICE IS NOT DAMAGED TO THE EXTENT THAT IT MALFUNCTIONS OR THAT BURRS HAVE BEEN PRODUCED THAT COULD DAMAGE TISSUES OR SURGICAL GLOVES. FUNCTIONAL CHECKS SHOULD BE PERFORMED WHERE POSSIBLE: MATING DEVICES SHOULD BE CHECKED FOR PROPER ASSEMBLY. MEDICAL DEVICES WITH MOVING PARTS SHOULD BE OPERATED TO CHECK CORRECT OPERATION (MEDICAL GRADE LUBRICATING OIL SUITABLE FOR STEAM STERILIZATION CAN BE APPLIED AS REQUIRED). ROTATING INSTRUMENTS (E.G. MULTIPLE USE DRILL BITS, REAMERS) SHOULD BE CHECKED FOR STRAIGHTNESS (THIS CAN BE ACHIEVED BY SIMPLY ROLLING THE INSTRUMENT ON A FLAT SURFACE). "FLEXIBLE" INSTRUMENTS, E.G. IM REAMERS, SHOULD BE CHECKED FOR DAMAGE TO THE SPIRAL ELEMENT. NOTE: STRYKER TRAUMA & EXTREMITIES TYPICALLY DOES NOT SPECIFY THE MAXIMUM NUMBER OF USES APPROPRIATE FOR RE-USABLE MEDICAL DEVICES. THE USEFUL LIFE OF THESE DEVICES DEPENDS ON MANY FACTORS INCLUDING THE METHOD AND DURATION OF EACH USE, AND THE HANDLING BETWEEN USES. CAREFUL INSPECTION AND FUNCTIONAL TEST OF THE DEVICE BEFORE USE IS THE BEST METHOD OF DETERMINING THE END OF SERVICEABLE LIFE FOR THE MEDICAL DEVICE. HOWEVER, FOR CERTAIN INSTRUMENTS END OF LIFE HAS BEEN DEFINED, VERIFIED AND SPECIFIED WITH EITHER A NUMBER OF USES OR AN EXPIRATION DATE. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED. LOST IN TRANSIT.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    UPON OPENING THE OMEGA PIN AND PLATE SET, IT APPEARS THAT THERE WAS SOME RUST OR POSSIBLY DRY BLOOD ON THE OMEGA STANDARD BARREL REAMER.

    Description of Event or Problem · 1

    UPON OPENING THE OMEGA PIN AND PLATE SET, IT APPEARS THAT THERE WAS SOME RUST OR POSSIBLY DRY BLOOD ON THE OMEGA STANDARD BARREL REAMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404942 COMBINATION REAMER ASSEMBLY OMEGA STANDARD ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER GMBH X20175

    Patients

    Seq Age Sex Outcome Treatment
    1 Other