SMITH & NEPHEW, INC. SYN F/T BRCH SZ 14; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Model Number 71366709 |
Device Problems
Nonstandard Device (1420); Dull, Blunt (2407); Material Deformation (2976)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/22/2020 |
Event Type
malfunction
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Event Description
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It was reported that, after procedure, this broach was noticed to be dull and not true to size.The device had been used to complete the procedure and no issues were reported during case.
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Manufacturer Narrative
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The associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device was found to be dull.A dimensional evaluation of the returned device could not confirm the stated failure mode.The returned device passed overall tooth profile with overlay 005375.A review of complaint history did not reveal additional complaints for the listed batch.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 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.Should 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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