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Catalog Number 72204037 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/19/2023 |
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 retrograde drill tip was stuck inside the tunnel when the the tibial tunnel was finished.The drill tip was completely removed.The procedure was completed without surgical delay using the same device.No further complications were reported.
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Manufacturer Narrative
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H10: h2: additional information on b5, e1, e2, e3 and g2.
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Event Description
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It was reported that during an arthroscopy, the retrograde drill tip was stuck inside the tunnel when the tibial tunnel was finished.The drill tip broke and it was completely removed with suture forceps.The procedure was completed without surgical delay using the same device.No further complications were reported.
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Manufacturer Narrative
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Internal complaint reference case (b)(4).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 entire distal drilling end fractured away, the antegrade drill, the retrograde drill, it's actuation wire and the orange depth gauge were not returned with the outer shaft both the orange hub and gray slider.There is biological debris on the returned device.An evaluation of the customer provided image showed the device laying on a blue surface with a broken tip.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 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 an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, 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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