It was reported that during trauma surgery, the medullary canal had been previously rimmed and one (1) meta-nail tibial 8.5mm x 33cm was placed, an attempt was made to block distally with sureshot and under fluoroscopy but it was not possible to place the screw after several attempts.The procedure was resumed, after a non-significant delay, using a different size s+n back-up device.Patient was not harmed as consequence of this problem.
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H6: health effect - impact code.Section h3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the reported failure.According to the report, the surgeon decided to change to another device of a different size and completed the surgery with a non-significant delay.Per report, the patient¿s health was not affected.Therefore, the impact to the patient beyond that which has already been reported, cannot be confirmed nor concluded.Should any additional relevant medical information be provided, this case would be re-assessed.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for intramedullary nail system revealed in preoperative planning that proper placement of implants are necessary to effectively treat patients using metallic surgical implants.A proper type and size of implant must be selected to insure effective treatment of patients.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected or insertion technique.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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