BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIALTY 4MM & 11MM TRIATHLON STYLUS PER FILE K1975

    MDR report key: 3150436 · Received June 6, 2013

    Report

    Report Number
    0002249697-2013-01848
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: AN EVENT REGARDING A FUNCTIONALITY/LOCKING ISSUES INVOLVING A SPECIALTY TRIATHLON GAP BALANCER/SIZER PER (B)(4) WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION SHOWS SIGNS OF USE AND THE SUPPLIER CONFIRMED THE DEVICE TO BE FULLY FUNCTIONAL PER SPECIFICATION. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE EVENT. -DEVICE HISTORY REVIEW: THERE WERE NO REPORTED DISCREPANCIES FOR THE REFERENCED LOT. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER REPORTED EVENTS FOR THE REFERENCED LOT. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE EVENT OCCURRED DUE TO USE ERROR BY THE SURGEON. THE SPECIALTY INSTRUMENTS TEAM CONFIRMED VIS DISCUSSION WITH THE CUSTOMER THAT THE SURGEON DID NOT FULLY UNDERSTAND THE PROPER UTILIZATION OF THE TRIATHLON GAP BALANCER. REVIEW OF THE TRIATHLON PRODUCT LITERATURE INDICATED THAT LSPK55 PROVIDES SUFFICIENT INSTRUCTIONS REGARDING THE PROPER USE OF THE TRIATHLON GAP BALANCER. ADEQUATE WARNINGS ARE PROVIDED IN THE IFU REGARDING THE UTILIZATION OF INSTRUMENTS PRIOR TO CLINICAL USE. THE EVALUATION PERFORMED BY THE SUPPLIER CONCLUDED THAT NO DEVICES ISSUES COULD BE OBSERVED AS THE DEVICE FUNCTIONED PER SPECIFICATION. THIS EVENT IS THEREFORE NOT RELATED TO THE MANUFACTURE OR DESIGN OF THE SUBJECT DEVICE.

    Additional Manufacturer Narrative · 1

    NO DEVICE EVALUATION, HISTORY REVIEW OR COMPLAINT HISTORY WAS PERFORMED AS NO DEVICES WERE RECEIVED OR IDENTIFIED. A REVIEW OF MEDICAL RECORDS WAS NOT PERFORMED AS NONE WERE PROVIDED AND THE EVENT HAS NO PATIENT FACTORS. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED FOR INSPECTION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS THE DEVICE WAS NOT RECEIVED BY STRYKER ORTHOPAEDICS. THE REPORTED EVENT REGARDING A NON FUNCTIONAL TRIATHLON GAP BALANCER WAS NOT CONFIRMED. CORRECTED DATA IN D 10 DEVICE IS NOT RETURNED

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE HAS REPORTED FROM THE SURGEON THAT DURING A SURGERY, THE TRIATHLON GAP BALANCER WAS NOT WORKING. IT WAS NOT POSSIBLE TO BLOCK THE SYSTEM DURING THE BALANCING TIME IN THE THEATER. THE SURGEON USED THE HAND TO BLOCK THE SYSTEM. THE LOCKER DID NOT WORK AT ALL.

    Description of Event or Problem · 1

    THE SALES REPRESENTAIVE HAS REPORTED FROM THE SURGEON THAT DURING A SURGERY THE TRIATHLON GAP BALANCER WAS NOT WORKING. IT WAS NOT POSSIBLE TO BLOCK THE SYSTEM DURING THE BALANCING TIME IN THE THEATER. THE SUREGON USED THE HAND TO BLOCK THE SYSTEM. THE LOCKER DID NOT WORK AT ALL.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE HAS REPORTED FROM THE SURGEON THAT DURING A SURGERY THE TRIATHLON GAP BALANCER WAS NOT WORKING. IT WAS NOT POSSIBLE TO BLOCK THE SYSTEM DURING THE BALANCING TIME IN THE THEATER. THE SURGEON USED THE HAND TO BLOCK THE SYSTEM. THE LOCKER DID NOT WORK AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251517 SPECIALTY 4MM & 11MM TRIATHLON STYLUS PER FILE K1975 INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other