It was reported that, during set up, a meniscus mender set was found to have faulty needles.The procedure was finished with a non-significant delay using a smith and nephew back up device.Patient was not harmed as consequence of this problem.Preliminary results of investigation showed that one of the meniscal suture loops was separated between the hub and shaft which makes it a reportable event.However, it was not possible to differentiate the devices, as no lot information is available on the devices.
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H3, h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.Insufficient product identification information was provided, and thus, a manufacturing record review could not be conducted.A complaint history review concluded this was a repeat issue.A visual inspection of the returned device found that it was not returned in its original packaging.There are two sets together with this complaint.Each is it its own separate container within the same plastic bag, but the lot to differentiate the devices cannot be determined, as no lot information is available on the devices.A visual inspection of device one shows that one of the meniscal suture loops is separated between the hub and shaft.One of the straight needles has debris in the lumen of the needle and the pink cap was partially attached to the hub of the needle.A visual inspection of device two shows that all pieces of the set do not show signs of physical damage or deformation.The complaint was confirmed, and the root cause was associated with device design.A corrective action for this failure mode is in place.
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