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Model Number 71513331 |
Device Problems
Material Fragmentation (1261); Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/27/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during a tka surgery, two (2) universal pin drivers failed to hold the profix bone spikes, both cracked while the surgeon placed the pins into the a/p block.Pieces of the devices were retrieved but it is unknown how.Surgery was resumed, without any delay, with a back-up device.Patient was not injured as consequence of this problem.Also, a genesis ii posterior stabilized constrained housing reamer dome have become dull and did not ream well.Surgery was resumed, without any delay, with the same device.Patient was not harmed as consequence of this problem.
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Manufacturer Narrative
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The device, used in treatment, 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 did not reveal additional complaints for the listed batch.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.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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Search Alerts/Recalls
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