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Catalog Number 7205335 |
Device Problems
Break (1069); Nonstandard Device (1420)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/18/2022 |
Event Type
malfunction
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Event Description
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It was reported that, during set up, when the full radius blade package was opened, it was found that the product blade was not exposed.There was a back-up device available and no delay was reported.There was no patient involvement.
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed it is not in its original packaging.The distal end of the inner shaft is fractured away and the interior of the shaft is exposed.The distal tip was not returned.There is biological debris on the returned device.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the inspection document found that for the fully assembled part, the blade must be visible.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include an impact event to the device inconsistent with normal use.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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