SMITH & NEPHEW, INC. VIS ADPT GUIDE LGNP KIT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Model Number V0100109 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/02/2022 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: case (b)(4).
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Event Description
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It was reported that, while using vis adpt guide lgnp kit during a tka, the tibial guide had too much varus built in.Surgeon had to use standard instrumentation to make proximal tibial cut.It is unknown how long surgery was delayed as consequence.On the other hand, the femoral guide was fine and resulted in a good cut.Patient was not harmed.
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Event Description
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It was reported that, while using vis adpt guide lgnp kit during a tka, the tibial guide had too much varus built in.Surgeon had to use standard instrumentation to make proximal tibial cut.It is unknown how long surgery was delayed as consequence.On the other hand, the femoral guide was fine and resulted in a good cut.Patient was not harmed.
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Manufacturer Narrative
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Internal complaint reference: case (b)(4).
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Event Description
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It was reported that, while using vis adpt guide lgnp kit during a tka, the tibial guide had too much varus built in.Surgeon had to use standard instrumentation to make proximal tibial cut.Surgery was delayed 5 min as consequence and resulted in additional, unintended resected bone.On the other hand, the femoral guide was fine and resulted in a good cut.The patient was not harmed beyond the described event.
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Manufacturer Narrative
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Internal reference number: (b)(4).
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Manufacturer Narrative
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The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, the tibial guide had too much varus built in; therefore, the surgeon had to use standard instrumentation to make proximal tibial cut resulting in additional, unintended tibial bone resection as well as a slight (5 min) surgical delay.It was communicated that the requested clinical documentation was not available due to protected health information.Reportedly, the patient was not harmed beyond the reported event.Based on the information provided, the clinical root cause cannot be definitively concluded and the patient impact beyond that which was reported can not be determined.No further medical assessment is warranted at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.This event was evaluated through our internal quality process and it was concluded that the root cause cannot be confirmed.All checks were found to be within visionaire standards.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This is a single use device, surgical technique or damage from misuse are likely potential factors that could contribute to the reported event.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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