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Model Number 71174934 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/25/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during an internal fixation surgery, the 2.0/2.7mm double-ended drill guide bent and became lodged with the sleeve.Also, the sleeve became bent and unable to drill through.Surgery was resumed, with greater than 30 minutes delay, with a back-up device.Patient was not injured as consequence of this problem.
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Manufacturer Narrative
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(b)(4).
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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.The contribution of the device to the reported event could not be corroborated.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 revealed similar events for the listed device, but no similar events for the 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.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.Additional information: d3.
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Search Alerts/Recalls
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