SMITH & NEPHEW, INC. GII OVAL PATELLA 5 PT. SZ GDE; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
|
Back to Search Results |
|
Model Number 71440842 |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/16/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Internal reference number: case: (b)(4).
|
|
Event Description
|
It was reported that gii oval patella 5 pt.Sz gde was broken.As this was noticed upon field inspection, there was not patient involvement.
|
|
Manufacturer Narrative
|
H3, h6: the associated device was returned and evaluated.The manufacturing process of the device did not contribute to the reported event.A visual inspection was conducted and confirms two of the sizing guides broken off.The broken pieces were returned with the device.A crack may have initiated during use or due to the heating and cooling associated with autoclaving.Plastics are vulnerable to brittle fractures due to over loading in a bending manner.This device shows significant signs of wear/usage.A review of complaint history revealed similar events for the listed device, but no similar events for the 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.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are probable causes of 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
|
|
|