SMITH & NEPHEW, INC. R3 OFFSET IMPACTOR TIP; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
|
Back to Search Results |
|
Model Number 71363077 |
Device Problem
Crack (1135)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/22/2021 |
Event Type
malfunction
|
Event Description
|
It was reported that a r3 offset impactor tip is cracked.As this was noticed upon inspection, there was not patient involvement.
|
|
Manufacturer Narrative
|
H3, h6: the associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned r3 offset impactor tip confirms the inner metal ring of the device is broken off.The broken piece was not returned with the device.This device also has extensive wear usage.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we do not have reason to suspect that the product failed to meet any product 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 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 for future complaints and investigate as necessary.
|
|
Search Alerts/Recalls
|
|
|