SMITH & NEPHEW, INC. GII SPC REAMTHRU CR TR SZ 6 LT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71433346 |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/08/2021 |
Event Type
malfunction
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Event Description
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It was reported that, after a tka, during equipment sterilization, a gii spc reamthru cr tr sz 6 lt was noticed to have a small crack in the back side.As this was noticed after procedure, the surgery had been completed without any surgical delay, with same device.Patient was not harmed as consequence of this problem.
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Manufacturer Narrative
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H3, h6: the device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the failure mode was confirmed.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.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 the device or 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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