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Model Number 72201518 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/25/2021 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Event Description
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It was reported that during an arthroscopy, instruments inside patient, the abrader 2.9 blade was broken, the broken pieces were removed from the patient.Then a abrader 3.5mm blade was used and it bent during use.The procedure was completed with a s+n back up device.Non-significant delay and no additional complications were reported.The status of the patient is recovered.There was no injury to the patient.
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Event Description
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It was reported that during an arthroscopy, the abrader 2.9 blade was broken.The broken pieces were removed from the patient.The procedure was completed with a s+n back up device.Non-significant delay and no additional complications were reported.The patient is recovered.
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Manufacturer Narrative
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B5 was updated.H3, h6: the reported device was received for evaluation.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.A visual inspection of the returned device found that it is not in its original packaging.The device is worn from use, and the outer shaft is bent.The inner shaft is broken into two pieces.There is debris on the inner and outer shaft.It was determined the device did not contribute to the reported event.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors, which could have contributed to the complaint event, include an application of excessive force or contact with another source.A complaint history review concluded this was an isolated event.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 review of risk management files found that the reported failure was documented appropriately.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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