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Model Number 242268 |
Device Problems
Material Fragmentation (1261); Scratched Material (3020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/15/2023 |
Event Type
malfunction
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Event Description
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It was reported by the sales rep that during an unspecified knee scope procedure, the 4k c-mnt scp,4.0,30,167,mitek device was scratched.During in-house engineering evaluation, it was determined that the device had broken lenses in the optical system.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
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Manufacturer Narrative
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Investigation summary: the complaint device was received at the manufacturing site and evaluated.During the service evaluation the following defects were identified: outer tube damaged, distal tip damaged, distal tip fiber damaged.Broken lenses in optical system.Per service reports, this complaint can be confirmed.The defective parts needs to be replaced to resolve the issues.As part of depuy mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.The faulty parts was identified as the root cause for the device failure during the service evaluation.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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Search Alerts/Recalls
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