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Model Number 71440472 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/22/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during step up, before a tka surgery, in one (1) gii tib try impl impactor the main screw came loose.This happened before use in patient.Surgery was performed, without any delay, with a back-up device instead.No health consequences were reported.
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Manufacturer Narrative
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H3, h6: the device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned gii tib try impl impactor confirmed the main screw on the head of the device is loose.The device also has excessive wear usage.A complaint history review found related failures; this failure mode will be monitored for future complaints 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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Search Alerts/Recalls
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