|
Model Number 71430415 |
Device Problem
Flaked (1246)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/02/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).
|
|
Event Description
|
It was reported that the gii ps hi flex isrt tr s5-6 9 is flaking and chipping.It is unknown when this was noticed and if there was a patient involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
|
|
Manufacturer Narrative
|
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.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.The contribution of the device to the reported event could not be corroborated.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.
|
|
Search Alerts/Recalls
|
|
|