It was reported that, during set up for a navio assisted tka surgery, it was noticed that the navio bone screw driver was stripped from continuous use and would not hold the pins any more.The procedure was finished with a smith and nephew back up device without delays.Since incident occurred before procedure, patient was not involved.
|
H3, h6: the navio bone screw driver, part number pfsr110164, intended for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.A complaint history review for similar reported/confirmed complaints has identified prior events.While all products meet required manufacturing specifications prior to release a serial number, lot number, or part revision is required to link the device to a dhr or nc investigation.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with wear and tear as a result of repeated use.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.
|