Evaluation results: evaluation of the returned device found the male buckle component at the bed connecting strap, on a single returned limb holder, was installed backward causing the bed connecting strap to slip when pulled.All buckles were compared to the product drawing and product sample.The male buckle installed incorrectly is a known issue related to documentation guiding the manufacturing process.The issue has been addressed internally via corrective action.Samples taken from multiple lots, at multiple facilities, found no other instances of incorrectly installed male buckles.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 warrant.Manufacturer reference file# (b)(4).
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