Udi: (b)(4).Investigation summary: according to the information provided, it was reported that the patient indication is right knee medial collateral ligament injury.During the surgery of ligament repair,opened the packing(before use), noted the body of anchor was deformed.Opened the 2nd one, still face with this issue.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.The second device was returned and evaluated.The visual inspection revealed that the anchor was bent near the mid-body, confirming this complaint.The anchor remained intact on the distal end of the inserter and the suture was intact within the handle at the proximal end of the inserter as intended.Our results indicate that this batch of product was processed without any incident related to the reported problem, and therefore there is no internally assignable cause for the reported problem.The storage conditions of these devices are unknown, and it is possible that they were exposed to high temperatures probably during transportation/ storage/ trunk stock resulting in the anchors to bend.This product should be stored in a cool dry place (below 80°f or 26°c), away from moisture and direct heat per ifu-108805.There was no information provided regarding this condition.A manufacturing record evaluation was performed for the finished device lot number:6l43169, and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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It was reported by the affiliate in china that during a ligament repair procedure on (b)(6) 2020 for the right knee medial collateral ligament injury, it was observed that the body of the lupine loop plus anchor w/oc device was deformed upon opening its package.During in-house engineering evaluation, it was determined that the device was bent in the middle section.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.
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