SMITH & NEPHEW, INC. GII MOD PAT REAMER GDE; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71440311 |
Device Problem
Connection Problem (2900)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/21/2020 |
Event Type
malfunction
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Event Description
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It was reported that there were metal shaving coming out of the impactor during the surgery, specifically from the grooves that lock the screws up and down.No delay reported.No patient injuries reported.An s&n backup was available.
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Manufacturer Narrative
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The associated device, used in treatment, were returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device clamp is loose, and device pin has fell out of device, rendering device inoperable.The device was manufactured in 2016 and shows signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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 do not have 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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