BLUE BELT TECHNOLOGIES HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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Catalog Number 110137 |
Device Problem
Defective Component (2292)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/21/2018 |
Event Type
malfunction
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Event Description
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A handpiece failure that has been caused by a bent drill guide has led, in the past, to conversion from computer-assisted to manual technique so the procedure could be completed.So, if this event were to recur in other surgery, it may require a medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.Therefore, this event is considered reportable pursuant to 21 c.F.R.§803.
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Manufacturer Narrative
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H10 h3, h6: the device, intended for use in treatment, was returned for investigation.The probable cause of the issue was a mechanical component failure.Dhr review found that no conditions that could contribute to the reported event were found.The reported product met manufacturing specifications prior to being released for distribution.A complaint history review found reports.Functional inspection was performed by inserting the long attachment backwards into the handpiece and could not be inserted, indicative of a bent drill guide support.This is reasonable because the drill guide support on the handpiece is aluminum.A relationship between the device and the reported event could be established.The malfunction is likely due to mechanical component failure from bending of the handpiece drill guide support.
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