SMITH & NEPHEW, INC. FEMORAL HEAD/NECK IMPACTOR; PRSTHSS, IP, SEMI-CONSTRAINED, METAL/PLYMR,NON-PRS, CLICM-PHSPHT
|
Back to Search Results |
|
Model Number 71360093 |
Device Problem
Break (1069)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/08/2020 |
Event Type
malfunction
|
Event Description
|
It was reported that during the tip on the femoral head/neck impactor broke while impacting the femoral head on the stem.It broke over the patient.All broken pieces of the femoral head/neck impactor were recovered from the patient.It is not known if smith & nephew back up was available.No supplemental information is currently available.
|
|
Manufacturer Narrative
|
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The plastic bumper of the device fractured into multiple pieces, rendering the device inoperable.Not all pieces were returned.The device was manufactured in 2016 and shows 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.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.
|
|
Manufacturer Narrative
|
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The plastic bumper of the device fractured into multiple pieces, rendering the device inoperable.Not all pieces were returned.The device was manufactured in 2016 and shows 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.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.
|
|
Search Alerts/Recalls
|
|
|