MalfunctionITQ

DONJOY

Received Sep 9, 2024 · Event occurred Aug 19, 2024

Report 9616086-2024-00073 · MDR key 20177224

Device

Generic name

X-rom Post-op Knee Brace

Manufacturer

Djo Llc

Model number

11-2181-9

Lot number

TJ31726221208

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 " FAST BUTTON CAN NOT BE FIXED MOVE IT SLIGHTLY THEN TENON OPENED."

Additional Manufacturer Narrative

IT WAS REPORTED "FAST BUTTON CAN NOT BE FIXED MOVE IT SLIGHTLY THEN TENON OPENED" 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.