SMITH & NEPHEW, INC. PIN PASSING DRILL TIP 2.4X381MM STRL; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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Catalog Number 7208678 |
Device Problem
Flaked (1246)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/16/2023 |
Event Type
malfunction
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Event Description
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It was reported that, during an arthroscopy, a pin passing drill tip ate the pin with eyelet after it was passed.When a guide was passed in the tibia, it was seen that the guide was releasing metal, even though the only thing it was passing through was bone and it had no contact with any hard surface.The procedure was successfully completed with a surgical delay of less than 30 minutes using a competitor 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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H10: internal complaint reference (b)(4).H3, h6: the shipping information was provided; however, the subject device was not made available to the designated complaint unit and thus a physical product evaluation could not be performed.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 of the reported event could not be determined since the device was not received for evaluation.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.If the product associated with this event is received at a future date, this investigation will be reopened for evaluation.
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Search Alerts/Recalls
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