BLUE BELT TECHNOLOGIES HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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Catalog Number 110137 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/28/2018 |
Event Type
malfunction
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Event Description
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It was reported that, during an ukr surgery, the handpiece jammed when burring the posterior aspect of the femur.It threw the jam error on the screen: after pressing dismiss, the system went back to the connected screen where the handpiece re-calibrated just fine, then went to home, but the drill did not budge an inch.Only the handpiece was swapped out and the rest of the case transferred without any problem.Surgery was not significantly delayed.The patient was not harmed.The results of investigation have pointed out that the snaplock assembly was broken, which makes it a reportable event.
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Manufacturer Narrative
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The navio handpiece, used in treatment, was jammed and would not home during a procedure.A device history record review found no conditions which could contribute to the reported event and the device met all manufacturing specifications during release for distribution.A complaint history review found similar reports and this issue will continue to be monitored.The navio handpiece was returned for further evaluation and the initial visual/functional inspection was performed, which confirmed the reported event.The snap lock nut was broken.A broken snap lock nut would prevent the snap lock from moving along the lead screw, causing the jam and homing issue.The root cause of this issue was found to be mechanical component failure.
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