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Model Number 7205325 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/27/2020 |
Event Type
Injury
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Event Description
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It was reported that during the procedure, the blade was showing metal debris in the joint when it is used and rubbing on the inside shaft of the blade; the procedure was successfully completed with less than 30 minutes delay using a back-up 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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Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that this event was already captured under (1219602-2020-01269) therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
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Manufacturer Narrative
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Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that this event was already captured under (1219602-2020-01269) therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
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Search Alerts/Recalls
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