SMITH & NEPHEW, INC. REF CUP POSITIONER/IMPACTOR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
|
Back to Search Results |
|
Catalog Number 71362299 |
Device Problems
Corroded (1131); Fracture (1260); Material Deformation (2976)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/20/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that, during a thr surgery, one (1) ref cup positioner/impactor broke.It remains uncertain how the procedure was completed or whether there was any delay.No injury was reported as a consequence of this issue.
|
|
Manufacturer Narrative
|
H10: internal complaint reference: (b)(4).H3: the sample is under evaluation by manufacturing site.
|
|
Manufacturer Narrative
|
H6: the associated device was returned and evaluated.The visual inspection revealed the threaded tip broke off the device.The piece was returned.The visual also reveals dents and rust in the handle.The device shows signs of significant wear and use.This inspection was conducted by naked eye.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 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.
|
|
Search Alerts/Recalls
|
|
|