DONJOY
Received Nov 6, 2024 · Event occurred Oct 21, 2024
Report 9616086-2024-00101 · MDR key 20616744
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 THAT ONE OF THE LOCKING MECHANISMS NO LONGER HOLDS AND THE HINGE WILL RANDOMLY UNLOCK. PATIENT HAD THE BRACE FOR 2 WEEKS BEFORE IT STOPPED WORKING. (PROBLEM WITH RED BUTTON)
Additional Manufacturer Narrative
ONE OF THE LOCKING MECHANISMS NO LONGER HOLDS AND THE HINGE WILL RANDOMLY UNLOCK. PATIENT HAD THE BRACE FOR 2 WEEKS BEFORE IT STOPPED WORKING. (PROBLEM WITH RED BUTTON). 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.