It was reported that during a tibial bone break surgery, the sureshot targeter didn't work after connecting to the controller, the information on the monitor showed " the targeter is invalid or broken, please exchange".Finally the c- arm was utilized to complete the surgery. no more information is available.
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It was reported that the device did not work after connecting to the controller.The associated sureshot targeter was returned and evaluated.A visual inspection of the device showed no obvious signs of damage on the part.A serial number was provided and the review of the manufacturing records for the listed serial number did not reveal any deviation from the standard manufacturing processes.A functional evaluation was performed by connecting the sureshot targeter to the sureshot interface unit which recognized the targeter.The device functions as intended.Thus, the stated failure could not be confirmed.The device was manufactured in 2015.The targeter is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Damage from repeated use can occur and some causes for the malfunction would include a broken cable, damaged connector, broken srom connection, and/or silicone overmolding failure.Our investigation found that the subject device has been previously evaluated for similar events and an upgrade to the targeter has taken place.A second generation targeter has been released and is available (please reference device (b)(4)) for use.The sureshot device user manual is available, identifying pre-operative requirements for use and troubleshooting suggestions if needed.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.
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