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Model Number 7209738 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/23/2020 |
Event Type
malfunction
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Event Description
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It was reported that during femoral reaming, no measurements were visible in the flexible 9mm cannula.The procedure was completed without significant delay using the same device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.No product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was an isolated event.A relationship, if any, between the subject device and the reported event could not be determined.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Manufacturer Narrative
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Internal complaint reference: (b)(4).H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A complaint history review concluded this was a repeat issue.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A visual inspection found faded measurement markings.The complaint was confirmed, and the root cause was associated with component failure.Factors that could have contributed to the reported event include inappropriate cleaning or maintenance of the device, or wear from repeated use of the device.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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