SMITH & NEPHEW, INC. JRNY UNI TIBIAL IMPACTOR; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
|
Back to Search Results |
|
Model Number 71441353 |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/06/2021 |
Event Type
malfunction
|
Event Description
|
It was reported that, during tka surgery, a jrny uni tibial impactor broke, outside of patient.Surgery was resumed, without any delay, with a back-up device.Patient was not injured as consequence of this problem.
|
|
Manufacturer Narrative
|
G3, h2, h3, and h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.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.Without the return of the actual product involved, our investigation could not proceed.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.G2: report source update.G4: add 510k code.
|
|
Manufacturer Narrative
|
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device fractured along the tip, rendering the device inoperative.The device shows signs of extensive use.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 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 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 future complaints and investigate as necessary.
|
|
Search Alerts/Recalls
|
|
|