SMITH & NEPHEW, INC. JOURNEY ART ISRT ASSM TOOL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
|
Back to Search Results |
|
Model Number 74018911 |
Device Problem
Break (1069)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 10/06/2020 |
Event Type
malfunction
|
Event Description
|
It was reported that the journey art insert assm tool has the handle broken.No case involved.
|
|
Manufacturer Narrative
|
Additional information in h6.Results of investigation: 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 device spring latch mechanism is broken rendering device inoperable.The device was manufactured in 2013 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.Internal complaint reference (b)(4).
|
|
Search Alerts/Recalls
|
|
|