BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE ADAPTER DIST. LAT. FEMUR RIGHT

    MDR report key: 6562101 · Received May 11, 2017

    Report

    Report Number
    0008031020-2017-00296
    Event Type
    Malfunction
    Date Received
    May 11, 2017
    Date of Event
    April 17, 2017
    Report Date
    August 3, 2017
    Manufacturer
    STRYKER GMBH
    Product Code
    HWC
    PMA / PMN Number
    K133440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT A PLATE ADAPTER DIST. LAT. FEMUR RIGHT WAS ALLEGED OF BREAKAGE DURING SURGERY COULD BE CONFIRMED. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO BE USER RELATED. THE MOST LIKELY CAUSE IS THAT THE SURGEON HANDLED THE DEVICE BRUSQUELY, THUS FORCING ITS FRACTURE. ALSO THE FOLLOWING FACTORS MAY HAVE CONTRIBUTED TO THE OCCURRENCE OF THE REPORTED EVENT: CONNECTION PIN, ADAPTOR NUT AND PLATE ADAPTOR WERE PRE-ASSEMBLED (INEXPERIENCED STAFF). THE DEVICE HAD REACHED THE END OF ITS SERVICEABLE LIFE (MORE THAN 7 YEARS ON THE MARKET). THE DEVICE INSPECTION REVEALED THE FOLLOWING: ONE OF THE THREE TEETH OF THE DEVICE WAS FOUND BROKEN. THE ASSEMBLY WAS DISASSEMBLED: REF# 703521 / LOT# KSS145568 AND REF# 702977 / LOT# K121897 WERE IDENTIFIED. NONE OF THEM PRESENT ANOMALIES. 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 ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO COMPLETE THE SURGERY IN MIS FORMAT USING THE AXSOS 5.0 TARGETING SET. IT WAS REPORTED THAT THE TEETH SNAPPED OFF FOLLOWING THE SURGEON LIFTING THE LEG TO HELP REDUCE THE FRACTURE. IT WAS REPORTED THAT LIKELY UNDO FORCE WAS APPLIED TO THE DEVICE. IT WAS REPORTED THAT AN OPENED INCISION TECHNIQUE WAS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO COMPLETE THE SURGERY IN MIS FORMAT USING THE AXSOS 5.0 TARGETING SET. IT WAS REPORTED THAT THE TEETH SNAPPED OFF FOLLOWING THE SURGEON LIFTING THE LEG TO HELP REDUCE THE FRACTURE. IT WAS REPORTED THAT LIKELY UNDO FORCE WAS APPLIED TO THE DEVICE. IT WAS REPORTED THAT AN OPENED INCISION TECHNIQUE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340749 PLATE ADAPTER DIST. LAT. FEMUR RIGHT SCREW, FIXATION, BONE HWC STRYKER GMBH K264690

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other