Corrected to reflect that device was not received for evaluation.Gtin added.An event regarding wear involving a cutting edge reamer was reported.The event was not confirmed.Method & results: device evaluation and results: the device was received on-site.However, the devices were not transferred to the complaint handling team because appropriate labelling/complaint information was not indicated on the package.Therefore, material, visual, dimensional and functional analysis could not be performed.Medical records received and evaluation: no patient medical records were available for review.Device history review: not performed as lot code information was not provided.Complaint history review: not performed as lot code information was not provided.Conclusion: it was reported that the reamer was not removing bone easily.The event could not be confirmed nor was the supplier was notified as the device was not returned for evaluation.Further information such as product identification and product evaluation are needed to complete the investigation for determining a root cause.If additional information and/or device becomes available to indicate further evaluation is warranted, this record will be reopened.
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