STRYKER TRAUMA KIEL NAIL HOLDING SCREW, TIBIA T2 TIBIA 10 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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Catalog Number 18060370 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/22/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
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Event Description
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It was reported that, during a tibial nail procedure, when it came time to attach the nail to the holding bolt, the threads inside the nail would not engage with the holding bolt.Multiple attempts with no success.A second nail was opened and the nail successfully engaged with the holding bolt.Two minute surgical delay reported.No adverse consequences were reported.
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Event Description
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It was reported that, during a tibial nail procedure, when it came time to attach the nail to the holding bolt, the threads inside the nail would not engage with the holding bolt.Multiple attempts with no success.A second nail was opened and the nail successfully engaged with the holding bolt.Two minute surgical delay reported.No adverse consequences were reported.
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Manufacturer Narrative
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Investigation determined that this device is concomitant and did not contribute to the reported failure.Upon functional inspection of the two devices, it was found that the connection between the reported nail and the reported nail holding screw was not possible.There was no sign of damage on the nail holding screw.However, threads of the nail were found damaged.Upon further evaluation, when the reported nail holding screw was used with a sample nail, the connection between them was found perfect.This suggests that the nail holding screw was not the immediate cause, but the nail was.
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