SMITH & NEPHEW, INC. GII SPC PRI SPACER BLOCK; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
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Model Number 71441265 |
Device Problems
Loose or Intermittent Connection (1371); Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/14/2021 |
Event Type
malfunction
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Event Description
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It was reported that the white retaining rings of the gii spc pri spacer block were missing.As this was noticed upon inspection, no patient was involved.
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Manufacturer Narrative
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The device, used in treatment, was not returned for evaluation.Therefore, a product analysis could not be performed at this time and the reported event could not be confirmed.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.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 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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