The reported event that a radial broach assy, size 2 rhead was alleged of breakage during surgery could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was most likely caused by improper inspection and functional testing of the device before usage.As stated in stryker¿s ¿instructions for cleaning, sterilization, inspection and maintenance¿, this is the best way of determining the end of serviceable life for the medical instrument.The device inspection revealed the following: the breakage surface was analysed.Its wavy trend reveals evident instantaneous zones.The fatigue zone could be identified as well.The device at issue underwent repeated stresses which resulted in fatigue breakage.A review of the device history was not possible.Any design, manufacturing and material issue can be excluded as a root cause of the event, though.Indeed, since it is known that the device at issue has been on the market for over 10 years, it is guaranteed that it has fulfilled its function.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.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.The instructions for cleaning, sterilization, inspection and maintenance (ot-rg-1 rev 3_l24002000 cleaning guide) were reviewed: ''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.''.
|