SMITH & NEPHEW, INC. TAN/FAN PERC DRILL GUIDE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number 71631021 |
Device Problem
Failure to Align (2522)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/12/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during a trigen tan surgery, the doctor faced several issues with its instruments.Also, there was mismatch/alignment between hole and drill bit.Surgery was resumed, with a greater than 30 minutes delay, with a competitor device.Patient was not harmed as consequence of this problem.
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Event Description
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It was reported that, during a trigen tan surgery, the doctor faced several issues with its instruments.Also, there was mismatch/alignment between hole and drill bit.Surgery was resumed, with a greater than 30 minutes delay, with a competitor device.Patient was not harmed as consequence of this problem.
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Manufacturer Narrative
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H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history over the lifetime of the device revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no 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.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.We consider this investigation closed.
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