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Model Number 71631123 |
Device Problem
Fracture (1260)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 07/14/2021 |
Event Type
Injury
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Event Description
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It was reported that, during an internal fixation surgery, a 4.0mm short ao pilot drill was fractured in the right femoral bone, and a fragment remained inside the bone.Surgery was resumed with the same device, it is unknown if there was any delay.The current health status of the patient is unknown.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, without the requested clinical information, the reported drill breakage could not be further assessed.The material composition of the possible retained drill is 17-4 ph stainless steel.The short pilot drill is an externally communicating device, it is neither manufactured nor intended for implantation.It is also not approved for long term internal tissue exposure and long-term implantation data is not available.The patient impact beyond the reported device breakage/retained foreign body during the procedure could not be definitively determined.Although unlikely, the potential for corrosion and local irritation/migration of the drill fragment could not be ruled out.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.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.A review of the risk management file revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This is a single use device, damage from misuse, excessive cleaning or rough handling are likely probable causes of the reported event.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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Event Description
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It was reported that, during an internal fixation surgery, a 4.0mm short ao pilot drill was fractured in the right femoral bone, and a fragment remained inside the bone.Surgery was resumed with the same device, without any delay.The current health status of the patient is unknown.
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Search Alerts/Recalls
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