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Catalog Number 72203165 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/24/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).
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Event Description
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It was reported that during an arthroscopy, the cannulated flexible drill felt used and did not have the length mark numbers any longer; the drill broke.The procedure was completed using a s+n back up device.There was no surgical delay.No further complications were reported.
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Event Description
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It was reported that during an arthroscopy, the cannulated flexible drill felt used and did not have the length mark numbers any longer; the drill broke inside the patient, all the pieces were removed with a passing pin and pituitary.The procedure was completed using a s+n back up device.There was no surgical delay.No further complications were reported.
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Manufacturer Narrative
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H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The device shows heavy wear from use, the laser etchings are barely legible.The distal end of the drill is fractured away and was not returned.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.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 or repeated force over time resulting in wear from use of the device.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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