SMITH & NEPHEW, INC. GII OVAL PATELLA 5 PT. SZ GDE; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71440842 |
Device Problem
Material Separation (1562)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/01/2020 |
Event Type
malfunction
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Event Description
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It was reported that after tka surgery, one of the plastic sizer pieces of the genesis ii oval patella 5 pt.Size gde came off the wheel, it snapped off.The procedure was finished using the same device, with no surgical delay, and no injury to the patient.
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Manufacturer Narrative
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Additional information in g4, h6 investigation results: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.Therefore, product analysis could not be performed at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.Should 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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