Model Number 9914PK01 |
Device Problem
Dull, Blunt (2407)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Device will not be returned for evaluation.If additional information becomes available, it will be provided on a supplemental report.Device discarded.
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Event Description
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It was reported that the osteotome in the kit was dull.It did not scrape any bone at all.It also seemed like a different shape, a little more thick and also did not have the jagged laser mark on the back of the osteotome.Needed to open hospital owned tray.This delayed the case.
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Event Description
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It was reported that the osteotome in the kit was dull.It did not scrape any bone at all.It also seemed like a different shape, a little more thick and also did not have the jagged laser mark on the back of the osteotome.Needed to open hospital owned tray.This delayed the case.
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Manufacturer Narrative
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The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.An inspection of the picture has shown that the evidence "the osteotome in the kit was dull" could not be confirmed, based on the blurred instrument on the picture.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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Search Alerts/Recalls
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