DONJOY
Received Sep 14, 2024 · Event occurred Aug 21, 2024
Report 9616086-2024-00072 · MDR key 20219170
Device
Product problems
- Mechanical Problem
- Unintended System Motion
- No Apparent Adverse Event
- Mechanical Problem
- Unintended System Motion
- No Apparent Adverse Event
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE RED BUTTON BROKE AND WILL NOT LOCK OUT. THE ROOT CAUSE OF THE COMPLAINT IS DAMAGED COMPONENT BASED ON OTHER DEVICES THAT HAVE BEEN EVALUATED. THE DEVICES LOCK BUTTON FAILED DURING MANUFACTURER TESTING CONFIRMED TO BE THE SAME MALFUNCTION FOUND IN REPORT NUMBER 9616086-2023-00007. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE RED BUTTON BROKE AND WILL NOT LOCK OUT .
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE RED BUTTON BROKE AND WILL NOT LOCK OUT. THE DEVICE WAS RETURNED TO ENOVIS FOR EVALUATION, PRODUCT WAS USED, DEFECTIVE HINGE RIGHT SIDE DON'T LOCK, ISSUE REPORTED BY THE CUSTOMER HAS BEEN CONFIRMED. THE ROOT CAUSE OF THE COMPLAINT IS DAMAGED COMPONENT BASED ON OTHER DEVICES THAT HAVE BEEN EVALUATED. THE DEVICES LOCK BUTTON FAILED DURING MANUFACTURER TESTING CONFIRMED TO BE THE SAME MALFUNCTION FOUND IN REPORT NUMBER 9616086-2023-00007.