|
Model Number 71674001 |
Device Problem
Mechanical Jam (2983)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/28/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported that, during trauma surgery, a trigen drill guide handle got stuck with a nail.Surgery was resumed, after a significant delay greater than 30 min, with a smith & nephew back-up device.Patient was not injured as consequence of this problem.
|
|
Manufacturer Narrative
|
The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.A nail was found to be seized onto the device, rendering the device inoperative.The drill guide handle has damage from use, and the mating nail has damage from attempted insertion.A review of complaint history based on the historical data revealed similar events for the listed batch.This failure mode will be monitored for future complaints 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.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device was found to be jammed to its matting component.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.We consider this investigation closed.
|
|
Search Alerts/Recalls
|
|
|