The associated sureshot targeter was returned and evaluated.Visual inspection of the product found no obvious damage.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.An error message was displayed which read, ¿sureshot targeter invalid or broken tool - please exchange.¿ thus, the stated failure was confirmed.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 71692851) 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.We consider this investigation closed.Should additional information be received, the complaint will be reopened.Credit has been issued for the device.
|