If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The complaint device was received and evaluated.Visual observations reveal the anchor was off the inserter but held in place by the suture.Upon observing under magnification, no anomalies were noted on the anchor.However, the pin on distal end of the inserter tip is bend.Although a definite root cause cannot be determined, it is a possibility that excess torque was applied when inserting the anchor at off angle which caused the inserter tip to bend.Other than this possibility, a root cause cannot be determined.Further, a review into the depuy synthes mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.At this point in time, no further action is warranted.A non-conformance search was performed for this product code (212851), lot (3897504) combination and no non-conformances were identified.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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.This report is being filed from the etq complaint management system actions (capa) to file usa fda mdr missed malfunctions.
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It was reported by the sales rep that during an unspecified surgical procedure, it was observed that the customer's mini lok q/a malfunctioned.The surgeon used another like device to complete the procedure.There were no reported patient consequences or delays.No further details were provided since the sales rep was not present at the case.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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