inforMED
MalfunctionHSB

REDEMPTION DUO HINDFOOT NAIL SYSTEM

Received Oct 24, 2024 · Event occurred Oct 10, 2024

Report 20522108 · MDR key 20522108

Device

Generic name

Rod, Fixation, Intramedullary And Accessories

Manufacturer

Vilex Llc

Patient

46 YR · Female

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

VILEX TRAY: REDEMPTION DUO HINDFOOT NAIL SET: HEEL CUP FELL OFF DURING ASSEMBLY. THIS PIECE CONTINUED TO FALL OFF WHEN ATTACHING THE LOCKING SCREWS FOR THE PATIENT IMPLANT. THE BASE OF THIS PIECE CRACKED DURING USE AND WOULD NO LONGER STAY IN PLACE WHILE LOCKING THE IMPLANT SCREW AND WOULD FELL OFF IN REPEATED ATTEMPTS OF USE. MANUFACTURER RESPONSE FOR HEEL CUP, VILEX: REDEMPTIONDUO HINDFOOT NAIL (PER SITE REPORTER). THEY WOULD BE RETRIEVING THE PRODUCT.