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Catalog Number 72204049 |
Device Problems
Break (1069); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/30/2023 |
Event Type
malfunction
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Event Description
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It was reported that during an acl surgery, after retrograde drilling the femoral tunnel with the trunav, the blade could not be properly retrieved back.The blade was stuck and in order to retrieve the trunav, the blade had to be forcibly broken, the broken pieces were retrieved,.The procedure was completed with a delay greater than 30 min using a back-up device.No further complications were reported.
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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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 was returned with the retrograde bit and actuator wire fractured off the shafts.The grey slider and orange depth guide are on the shaft and there is biological debris on all returned items.A functional evaluation could not be performed due to the device being broken.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 has been associated with unintended use of the device.Factors that could have contributed to the failure include excessive force during use, failure to retract the guidewire far enough back before attempting to deploy the blade, using the reverse function while drilling, attempting to deploy the blade while still inside the bone tunnel, or an impact event 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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