It was reported that during surgery, it was noticed that the screwdriver in the sterile kit showed traces of rust.The procedure was completed using another smith & nephew device with no surgical delay, and no injury to the patient.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.Therefore, product analysis could not be performed at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Some potential probable causes for this event could include damaged product, implant corrosion or wear.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.A relationship, if any, between the device and the reported incident could not be corroborated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation 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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