SMITH & NEPHEW, INC. RDCE FRCPS W/ PTS {} BRD; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
|
Back to Search Results |
|
Model Number 71173377 |
Device Problems
Break (1069); Material Twisted/Bent (2981)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/03/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that, during use, a rdce frcps w/ pts {} brd broke.The procedure was completed, without delay, using a s+n back-up device.Patient was not harmed.
|
|
Manufacturer Narrative
|
Internal complaint reference: (b)(4).
|
|
Manufacturer Narrative
|
H3, h6: the device was not returned for evaluation but the picture was reviewed, and revealed that the device was broken and bent.A review of complaint history of the previous 12 months revealed similar events for the listed device, 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 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 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.The contribution of the device to the reported event could be corroborated as the device was broken and bent and a backup device was needed.Based on this investigation, the need for corrective action is not indicated.Should the device or 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
|
|
|