SMITH & NEPHEW, INC. GII UNIVERSAL EXTRACTOR; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 71440366 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/29/2024 |
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, using the gii universal extractor, when it was attempting to take the tibial punch out with the slap hammer and it broke off.All the pieces were accounted for.The procedure was resumed, using a s+n back-up device.The surgery was not delayed.Patient was not injured as consequence of this problem.
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Manufacturer Narrative
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The associated device was returned and evaluated.The visual inspection revealed that all pieces were returned and the extractor shaft is fractured.The clinical/medical investigation concluded that as of the date of this clinical-medical evaluation, the requested op notes and x-ray imaging have not been provided.Based on the limited information provided, a clinical root cause cannot be concluded.Patient impact beyond the reported device breakage would not be anticipated as the procedure was reportedly completed with the backup, without delay, with all pieces accounted for.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.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.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should 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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