DONJOY
Received Feb 26, 2025 · Event occurred Feb 4, 2025
Report 9616086-2025-00013 · MDR key 21475083
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
Description of Event or Problem
IT WAS REPORTED: "PATIENT COMPLAINED OF THE HINGE ON THE BRACE COMING UNLOCKED FROM EXTENSION ESPECIALLY WHEN HE WAS SLEEPING. UPON EXAMINATION, THE BRACE HINGE UNLOCKS WITH VERY MILD FORCE OF FLEXION, HINGE WON'T STAY IN LOCKED POSITION.''
Additional Manufacturer Narrative
IT WAS REPORTED: "PATIENT COMPLAINED OF THE HINGE ON THE BRACE COMING UNLOCKED FROM EXTENSION ESPECIALLY WHEN HE WAS SLEEPING. UPON EXAMINATION, THE BRACE HINGE UNLOCKS WITH VERY MILD FORCE OF FLEXION, HINGE WON'T STAY IN LOCKED POSITION.'' 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 MANUFACTURING 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.