During planing of the calcar in total hip replacement, there was a fracture of the calcar.This was not considered as a product complaint at the time but after further use of the instrument surgeon believes it was the instrument itself that caused this.Surgeon was not using the planer at speed, and was aware of how aggressive it was.20 minute delay to procedure.No ae to patient outcome post surgery: satisfactory.
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(b)(4).No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.The investigation could not draw any conclusions regarding the reported event.Based on the inability to determine a root cause, the need for corrective action was not indicated.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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