SMITH & NEPHEW, INC. R3 OFFSET IMPACTOR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
|
Back to Search Results |
|
Model Number 71368569 |
Device Problem
Material Deformation (2976)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/22/2021 |
Event Type
malfunction
|
Event Description
|
It was reported that the offset impactor tip is broken.The end piece has stripped and is causing trouble during impaction, because it will not seat or screw onto the cup fully.The procedure was completed using a sn backup device.No surgical delay or injury to the patient was reported.
|
|
Manufacturer Narrative
|
H3, h6: the device, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.The device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation 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
|
|
|