|
Model Number 71129402 |
Device Problem
Component Missing (2306)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/16/2021 |
Event Type
malfunction
|
Event Description
|
It was reported that during a field inspection the ipg mis dcf ap ct blk 3 was noted to be rusty and discolored, the extramedular alignment rod was broken, the gii quick connect handle dented and did not retract, the ipg ps high flex impctr hd 1-2 gii ps high flex impctr hd 3-8, gii tibial base impactor, gii narrow pcl retractor, 11mm gns ii tibial drill with burrs and gouges and outer housing cap with one component missing and broke.No case reported; therefore, there was no patient participation.
|
|
Manufacturer Narrative
|
The device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The handles are cracked on the device, rendering the device inoperable.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.The device shows signs of extensive use.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.
|
|
Search Alerts/Recalls
|
|
|