SMITH & NEPHEW, INC. FEMORAL HEAD/NECK IMPACTOR; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
|
Back to Search Results |
|
Catalog Number 71360093 |
Device Problem
Collapse (1099)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 07/29/2019 |
Event Type
malfunction
|
Event Description
|
It was reported that during procedure the black impactor done broke.No injuries or delays reported.Backup device available.No more information provided yet.
|
|
Manufacturer Narrative
|
The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.A section of the plastic impactor tip on the device fractured off and was not returned.The tip also had numerous nicks in the surface.The device was manufactured in 2013 and exhibits signs of extensive wear/usage.A review of complaint history did not reveal additional complaints for the listed batch.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 have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.
|
|
Manufacturer Narrative
|
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that it is unknown if this device broke above the incision, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
|
|
Search Alerts/Recalls
|
|
|