DONJOY
Received Oct 30, 2024 · Event occurred Oct 2, 2024
Report 9616086-2024-00090 · MDR key 20575055
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 HINGE/RED LOCK KEEPS UNLOCKING WHILE PATIENT IS AMBULATING AFTER A SHORT TIME OF USE. THE PATIENT'S MOM DID NOT INDICATE THAT ANY HARM WAS DONE, JUST THAT IT KEPT COMING UNLOCKED WHILE THE PATIENT WAS AMBULATING. THE BRACE HAS NOT BEEN RETURNED FOR EVALUATION. 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 HINGE/RED LOCK KEEPS UNLOCKING WHILE PATIENT IS AMBULATING AFTER A SHORT TIME OF USE. THE PATIENT'S MOM DID NOT INDICATE THAT ANY HARM WAS DONE, JUST THAT IT KEPT COMING UNLOCKED WHILE THE PATIENT WAS AMBULATING.