BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1/8" HEX DRIVE

    MDR report key: 3092214 · Received May 3, 2013

    Report

    Report Number
    0002249697-2013-01516
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K123166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INABILITY TO TURN LOCKING SCREWS WITH A TRIATHLON 1/8¿ HEX DRIVE WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION CONFIRMED THE EVENT. VISUAL INSPECTION: THE EVENT WAS CONFIRMED. SIGNIFICANT WEAR OF THE RETURNED DEVICE, LOT SCZH05, WAS OBSERVED ON THE HEX HEAD WHEN COMPARED TO A THE SAME PART, LOT SCSA06, PULLED FROM FINISHED GOODS. THE WEAR OBSERVED IS CONSISTENT WITH THE APPROXIMATE SERVICE LIFE OF 7 YEARS EXPERIENCED BY THE DEVICE AND HIGH USAGE. DIMENSIONAL AND FUNCTIONAL INSPECTIONS WERE NOT PERFORMED AS THE DEVICE DISPLAYED WEAR INDICATIVE OF SIGNIFICANT USE AND CONSISTENT WITH END OF SERVICE LIFE CONDITIONS. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS IT WAS REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION ASSOCIATED WITH THE EVENT. -DEVICE HISTORY REVIEW: THERE WERE NO REPORTED DISCREPANCIES FOR THE REFERENCED LOT. -COMPLAINT HISTORY REVIEW: THERE HAS BEEN 1 OTHER SIMILAR EVENT FOR THE REFERENCED LOT. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE 1/8" HEX DRIVE COULD NOT PERFORM IT'S INTENDED FUNCTION OF TURNING LOCKING SCREWS DUE TO SIGNIFICANT WEAR OF THE HEX HEAD (TIP). AS THE DEVICE WAS USED FOR APPROXIMATELY 7 YEARS, THE WEAR DUE TO HIGH USAGE INDICATES THE EVENT IS A RESULT OF THE 1/8" HEX DRIVE REACHING THE END OF IT'S FINITE SERVICE LIFE. AS THE DEVICE WAS SUCCESSFULLY USED FOR APPROXIMATELY 7 YEARS, THERE IS NO INDICATION TO SUGGEST ANY MANUFACTURING OR MATERIAL NON-CONFORMANCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FINAL COMPONENT ASSEMBLY, PRIOR TO CEMENTING IN OF COMPONENTS, WHILE ATTENDING TO TORQUE THE DISTAL TIBIAL AUGMENTS TO THE TIBIAL TRAY, THE 1/8" HEX DRIVER SHAFT STARTED TURNING IN THE HEX RECEPTACLE OF THE LOCKING SCREW WITHOUT A CORRESPONDING REVOLUTION OF THE LOCKING SCREW ITSELF. RECOGNIZING THIS LACK OF PROGRESS IN TIGHTENING OF THE LOCKING SCREW ANOTHER 1/8" HEX DRIVER SHAFT WAS OBTAINED FROM ANOTHER INSTRUMENT TRAY AND THE LOCKING SCREW WAS TORQUED DOWN TO THE REQUIRED AMOUNT AS INDICATED BY THE CLICKING SOUND EMANATING FROM THE TORQUE LIMITING HANDLE. THERE WAS ONLY ABOUT A 20 SECOND DELAY IN THIS CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FINAL COMPONENT ASSEMBLY, PRIOR TO CEMENTING IN OF COMPONENTS, WHILE ATTENDING TO TORQUE THE DISTAL TIBIAL AUGMENTS TO THE TIBIAL TRAY, THE 1/8" HEX DRIVER SHAFT STARTED TURNING IN THE HEX RECEPTACLE OF THE LOCKING SCREW WITHOUT A CORRESPONDING REVOLUTION OF THE LOCKING SCREW ITSELF. RECOGNIZING THIS LACK OF PROGRESS IN TIGHTENING OF THE LOCKING SCREW ANOTHER 1/8" HEX DRIVER SHAFT WAS OBTAINED FROM ANOTHER INSTRUMENT TRAY AND THE LOCKING SCREW WAS TORQUED DOWN TO THE REQUIRED AMOUNT AS INDICATED BY THE CLICKING SOUND EMANATING FROM THE TORQUE LIMITING HANDLE. THERE WAS ONLY ABOUT A 20 SECOND DELAY IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194061 1/8" HEX DRIVE INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH SCZH05

    Patients

    Seq Age Sex Outcome Treatment
    1 Other