The associated complaint device was returned and evaluated.A visual inspection confirms the trigen medium hexdriver tip broke off into the screw.The screw was not returned for evaluation.Per the complaint description this piece could not be recovered.This instrument shows significant signs of use and wear.This device was manufactured in 2008.A clinical evaluation was conducted and based on the limited information provided the root cause of the tip of the inner capture portion breakage cannot be determined.However, based on the age of the device age related cannot be ruled out as a contributing factor.The 420/ 465 stainless steel are not implantable alloys; therefore, long-term implantation data is not available.The impact to the patient is the retained non-bio-inert fragment of the externally communicating device, additional radiological imaging/exposure, and although not likely since the tip is retained in the screw, possible micro-motion cannot be completely ruled out.No further clinical/medical investigation is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.
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