SMITH & NEPHEW, INC. GII MIS DCF DISTAL CUT BLK; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71441147 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/19/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during set up or inspection, prior to tka, it was noticed that the smooth pin is stuck in gii mis dcf distal cut blk.No case reported; therefore, there was no patient involvement.
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Manufacturer Narrative
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H6: the associated device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.A pin is lodged into the device and can't be removed rendering it inoperable.The device show signs of extensive use.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 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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