SMITH & NEPHEW, INC. DBL OFFSET BROACH HDLE LT; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Model Number 71360089 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference case (b)(4).
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Event Description
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It was reported that during efip inspection failure, broaches not locking once inserted broach wiggles.No case involved.
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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 could not confirm the stated failure mode.The device was manufactured in 2009 and shows signs of extensive use.A functional evaluation of the returned device confirms the stated failure mode.The locking mechanism on the device is worn, rendering the device inoperable.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.At this time, we do not have 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.
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Search Alerts/Recalls
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