It was reported that during surgery, the flexible connector broke while inside the patient.Which resulted in no expansion of pulp.Delay 30 minutes and no injury reported.No backup device available and since the bone marrow couldn¿t be expanded as planned, the original main nail could not be used, so a smaller size was used to complete the surgery.
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Additional information: g3.The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The flex shaft fractured at the first flex joint closet to the chuck end, rendering the device inoperable.The device was manufactured in 2014 and shows signs of extensive wear/usage.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should 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.
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