One polarstem collar reamer guide, used in treatment was returned for evaluation.Visual inspection reveals, that the hook has fractured around the metal pin and is separated from the rest of the device.The spring holding the hook in position was not returned.Dents are observed at several location of the hook.Material analysis revealed, that the fracture happened, due to overloading.A review of the production documentation did not reveal any deviation from the standard manufacturing processes.Dimensional evaluation of the relevant design features did not detect any dimensional deviation.A review of complaint history identified.However, two complaints with a similar failure mode.A thorough medical assessment could not be performed, as no further medical documents were available.A review of the design was performed.It was observed, that the hook may contact the reamer if it is not fully engaged in the rasp during reaming.Functional evaluation with reference parts showed, that this failure mode is compatible with the dents observed on the returned hook.Based on the performed investigation, it is assumed that foreign material prevented the hook to fully engage in the rasp.Which, led the reamer to hit and fracture the hook during reaming.A new design of the device has been released in order to prevent the reoccurrence of this issue.The root cause is attributed to insufficient design specifications.Further investigations have been initiated to review the performance of this device.This complaint has been reopened for reporting reasons, according to the current procedure.No additional information became available.Smith and nephew will monitor this device for further similar issues.The device will be archived.
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