It was reported that, during surgery, the cable of the sureshot targeter was not able to connect to the host monitor ("sureshot targeter not found").A change in the surgical technique (free hands to insert the screw) was necessary to complete the case with no significant delays (fewer than 30 minutes).The patient was not harmed.
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The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device shows signs of extensive use.A function evaluation of the returned device confirmed the stated failure mode.After plugging the device into a monitor, the error message, "sure shot targeter - invalid or broken tool please exchange," appeared.A review of the complaint history for the listed part revealed prior complaints for the listed failure mode but no other complaints with the same serial number as this is a unique serial device.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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