Conclusion: evaluation of the returned device found the box stitch that connects the cuff and connecting strap is broken causing the restraint to come apart.The ends of the exposed threads display a break with elongation of the thread fibers indicating the failure is the result of applying a tensile strength past the threshold of the box stitch.The customer admitted that the patient was in an agitated state and was aggressive.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.(b)(4).
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