SMITH & NEPHEW, INC. LGN TIBIAL CUTTING BLOCK RIGHT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71434332 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Event Description
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It was reported that, during a tka surgery, a genesis pin and drill set became stuck in a pin hole of the legion tibial cutting block right.The surgeon was attempting to pre drill his first pin in order to pin the tibial cutting block in place, and the drill caught in the hole and would not turn.The surgeon described it as seeming like the drill was too big for the pin hole.He was able to remove the drill from the patient¿s tibia, while the drill was still stuck in the cutting block, without any difficulty.Surgery was resumed, without any delay, with the same device.Patient was not harmed as consequence of this problem.
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Manufacturer Narrative
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Results of investigation: the devices, used in treatment, were returned for evaluation.A visual inspection of the returned devices confirms the genesis pin and drill set is stuck inside of the lgn tibial cutting block right, rendering both devices inoperable.The devices show signs of significant wear and use.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.These devices are reusable instruments that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
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