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Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Investigation summary: two devices were received and inspected.Visual inspection on first device shows that the grasping wire loop was deformed/bent.It is possible that the bent condition the wire could contribute to the reported condition.For bent condition, the root cause of this failure can be attributed to user technique, excessive force applied.Upon testing, the slider of the device was pushed to the various positions, and the grasping wire would extend slight and would not retract back in tube as intended.It seems like the grasping wire was separated or internal component got broke.This condition could also contribute to the reported condition.The complaint can be confirmed for the first device.From past failure investigations, it was observed that the grasping wire was separated from the slider which is likely due to inadequate fixation of the proximal end of the wire (hypotube) with the set screw during the manufacturing process.The set screw provides the connection between the slider and grasping wire.This failure was evaluated via nr-0107408 and pia 1317437.The full investigation and root cause will be documented via (b)(4).Visual inspection on the second device shows that the grasping wore looks good in shape.Upon testing, the slider of the device was pushed to the various positions, and the grasping wire was extending or retracting as intended.Hence, the complaint cannot be confirmed for the second device as no defect was noticed.The overall complaint can be confirmed since one of the devices shows defect.No anomalies were visually observed on the exterior of the devices.A manufacturing record evaluation was reviewed, no non-conformances were identified for the reported part 251723- lot 5l13598 number combination.At this point in time no further action is warranted.Depuy 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.Device history review: a manufacturing record evaluation was reviewed, no non-conformances were identified for the reported part 251723- lot 5l13598 number combination.
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It was reported by the affiliate in (b)(6) that during an arcr (arthroscopic rotator cuff repair) surgical procedure, it was observed that the surgeon was not able to grasp the suture with the ideal sutgrasper 60 deg *ea.A second ideal sutgrasper 60 deg *ea was used with the same lot and again it failed to grasp.The procedure was completed using a replacement with a different lot number.No patient consequence was reported, however there was a surgical delay of less than 30 minutes.There was a delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.During in-house engineering evaluation, it was determined that the grasping wire loop on the device was deformed/bent.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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