It was reported, facility staff noted several small holes in the packaging of the unused flexor shuttle tibial guiding sheath.This device did not make patient contact.Additional information regarding the storage conditions for the device has been requested, but is not available at this time.
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Initial report.It was reported, facility staff noted several small holes in the packaging of the unused flexor shuttle tibial guiding sheath.This device did not make patient contact.Additional information regarding the storage conditions for the device has been requested, but is not available at this time.Additional information: device was not returned.Investigation - evaluation.Reviews of the complaint history, device history record, documentation, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device history record shows no nonconforming events which could contribute to this failure mode.As there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.Furthermore, reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.An ifu is provided with this device, which states the device is ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile of package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided and no product returned, investigation has concluded that shipping, handling, and / or storage of the complaint device contributed to this incident.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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