Device evaluation: visual inspection of the returned precice nail revealed that the housing tube had cracks at the anti-rotation lug or the crown region and the anti-rotation lug was broken at least in two pieces.One piece of the lug was returned with the nail and based on the complaint description the other piece/pieces were left in the patient's medullary canal.No objective evidence has been provided for the pieces left inside the patient.The reported loss of distraction is likely due to the broken anti-rotation lug.Based on provided information and the type of breakage observed, it is likely that the nail broke due to stress generated from weight bearing activities and the surgeon indicated that possibility as well.Per the precice instructions for use, "the precice nail cannot withstand the stresses of full weight bearing.Patients should utilize external support, and/or restrict activities as directed by the physician until consolidation occurs¿.The work order was reviewed and confirmed the device passed all inspections per the acceptance tests.The manufacturing x-ray image showed the anti-rotation lug (crown) was seated properly in the housing body during manufacturing.Device records review: a review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.If any additional information is provided, a supplemental report will be submitted.
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