Aspen surgical received a letter from the fda (mw5086893) indicating that a needle broke during a procedure.Incident occurred at the end user.Manufacturing lot number was provided for review.Medwatch letter indicated the following, "needle used during orthopedic surgery, tip broke off into bone.Surgeon used product during orthopedic surgery.Bit broke off in bone and tech noticed it.Surgeon was then notified." no additional information was provided.No customer information was provided.A review of the device history record was completed.No non-conformance's were noted relating to the reported issue.No further information is available on the product.Based on this information, the root cause can not be established and no further action is required.Device not available.
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