SMITH & NEPHEW, INC. MI TRIAL FEM HEAD 32 -3; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71369714 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2021 |
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 field inspection, it was found that the bottom piece of a mi trial fem head 36 +0, a mi trial fem head 32 -3 and a mi trial fem head 32 +4 is broken so the neck trials cannot stay attached to them (case: (b)(4)).No case involved; therefore, there was no patient involvement.
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Manufacturer Narrative
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The associated device was returned and evaluated.The manufacturing process of the device did not contribute to the reported event.A visual inspection was conducted and confirmed the device is broken, rendering the device inoperable.This device also shows signs of significant wear and usage.A review of complaint history revealed 2 similar events for the listed part number.No adverse trend was found for this event.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are 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 future complaints and investigate as necessary.We consider this investigation closed.
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