SMITH & NEPHEW, INC. GII P/S CONS HOUSING REAM DOME; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
|
Back to Search Results |
|
Catalog Number 71440145 |
Device Problems
Fracture (1260); Difficult or Delayed Separation (4044)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/17/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that, during a tka, both gii p/s cons housing ream dome and a gii patellar reamer shaft got stuck together, as consequence the gii p/s cons housing ream dome broke off.No pieces fell inside the patient.Surgery was resumed, after a non-significant delay, implanting a cr (cruciate retaining) gen ii system.No patient harm was reported.
|
|
Manufacturer Narrative
|
H10: internal complaint reference: (b)(4).
|
|
Manufacturer Narrative
|
Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the associated device was returned and evaluated.A visual inspection of the returned device reveals the device fractured into two pieces.The device shows signs of significant wear and use.A functional evaluation reveals the ring from the reamer dome is not getting stuck on the patellar reamer shaft.The ring is attaching and detaching as intended.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.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.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.Corrected data: (sample returned for analysis), h6 (medical device problem code).
|
|
Search Alerts/Recalls
|
|
|