The reported event that a proximal phalangeal broach, size 1 sr pip has a loose color band could be confirmed.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by inappropriate device maintenance/handling and device useful life exceedance.The reported event occurred on (b)(6) 2015 and the device was manufactured on 12-jun-2008, meaning that it has been in working order for more than 6 years, a significant amount of time.The useful life of re-usable medical 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.As proved by the state of the received device, these things were not performed properly.The handle of the device shows several scratches on its low part.The color band can be easily detached from the end cup.The color band is visibly damaged and deformed.It results scratched and discolored in several areas, inside and outside.The tip of the device is intact.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.The cleaning and sterilization guide (ot-rg-1 en rev-2 l24002000 rev.N cleaning & sterilization guide_2015-8332) was 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.¿ 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.
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