SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE LT SZ 3-4 9MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER
|
Back to Search Results |
|
Model Number 74025641 |
Device Problem
Unsealed Device Packaging (1444)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/12/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Internal complaint reference (b)(4).
|
|
Event Description
|
It was reported that the sterile packaging of two (2) journey ii cr insert xlpe left size 3-4 9mm, intended to be used on a tka, were opened inside a sealed box, each in it's own box.Surgery was performed, without any delay, with a back-up device instead.Patient was not injured as consequence of this problem.
|
|
Manufacturer Narrative
|
D8, h3, h6: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device's packaging was found to be unsealed.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, 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.A contribution of the device to the reported event could be corroborated as the device's packaging was compromised.Some potential probable causes for this event could include packaging damage in transit or storage.Based on this investigation, the need for corrective action is not indicated.This issue was evaluated through our internal quality process and determined to be isolated at this time.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
|
|
|