SMITH & NEPHEW, INC. MI Z HANDLE ACET REAMER; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
|
Back to Search Results |
|
Model Number 71364073 |
Device Problem
Incomplete or Inadequate Connection (4037)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 10/20/2020 |
Event Type
malfunction
|
Event Description
|
It was reported that, upon set up / inspection process, prior to thr surgery, was noticed that inner piece of the mi z handle acet reamer did not close properly preventing it from sliding through outer sleeve.The procedure was finished using a smith and nephew back up device, with no surgical delay and no injury to the patient.
|
|
Manufacturer Narrative
|
H3: h6: the associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The acet reamer clam shell has a cracked weld rendering the device inoperable.The device was manufactured in 2017 and shows signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed 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.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.We consider this investigation closed.
|
|
Search Alerts/Recalls
|
|
|