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Model Number 71430766 |
Device Problems
Crack (1135); Difficult or Delayed Positioning (1157); Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/22/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that, during a tka surgery, a genesis ii dished articular insert trial size 3-4 9mm was noticed to be cracked and was not seating during the procedure.Surgery was performed, without any delay, with the same device.Patient was not harmed as consequence of this problem.While the device was being cleaned and decontaminated the fracture opened.
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Manufacturer Narrative
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Results of investigation: the device was not returned for evaluation and the reported event could not be confirmed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.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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Search Alerts/Recalls
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