SMITH & NEPHEW, INC. EVOS SMALL 2.0MM DRILL W/AO QC SHORT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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Model Number 71175021 |
Device Problem
Defective Device (2588)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/21/2020 |
Event Type
malfunction
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Event Description
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It was reported that the drill got stuck in the 2.0mm drill guide.It is unknown when the event occurs, how was the surgery finish, if there was a backup from smith and nephew available to complete the procedure and if there was any patient involved in the case.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Event Description
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It was reported that the drill got stuck in the 2.0mm drill guide, causing the device was snapped.It is unknown when the event occurs, how was the surgery finish, if there was a backup from smith and nephew available to complete the procedure, and if there was any patient involved in the case.
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Manufacturer Narrative
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Updated event: description of problem.
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Manufacturer Narrative
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Updated d4: lot number and udi.
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Manufacturer Narrative
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Results of investigation: the device, intended use in treatment, was returned for evaluation.A visual inspection confirmed the evos small 2.0mm drill w/ao qc short is broken into two pieces.The device shows significant signs of wear/usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation 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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