SMITH & NEPHEW, INC. GII SPC REAMTHRU CR TR SZ 6 RT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
|
Back to Search Results |
|
Model Number 71433356 |
Device Problems
Crack (1135); Material Fragmentation (1261)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/16/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Internal reference: (b)(4).
|
|
Event Description
|
It was reported that, after cleaning when the set was being re-assembled, it was found that metal separated/cracked from a gii spc reamthru cr tr sz 6 rt.No case involved; therefore, there was no patient involvement.
|
|
Manufacturer Narrative
|
The associated device was returned and evaluated.A visual inspection confirms a fracture and deformation of the fixation rails in the ream through slot of the femoral trial.The fracture and deformation is likely due to the load applied to the trial during the impaction of the trial onto the femur.If the loads applied exceed the strength of the material, a fracture may occur.This device exhibits signs of significant use and wear.A review of complaint history based on the historical data revealed similar events for the listed batch, 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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.As the device broke and it cannot longer fit its purpose, the contribution of the device to the reported event could be corroborated.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 future complaints and investigate as necessary.We consider this investigation closed.
|
|
Search Alerts/Recalls
|
|
|