Device not returned.Therefore this report is based solely on customer report.The dhr for lot 0233t191 was reviewed and found that no ncrs were associated with this lot and a sampling of units passed all testing prior to release for shipment.There does not appear to be a trend for this type of failure.Historical complaint data review found one other similar complaint for clips breaking on 2789q.In that instance, the device was returned and evaluated and a void was found in the plastic material of the prong where the break occurred, which may have weakened the prong.Without the return of the device, the reported issue cannot be confirmed.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.Manufacturer reference file #(b)(4).
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