MalfunctionHSB

REDEMPTION DUO HINDFOOT NAIL SYSTEM

Received Nov 13, 2024 · Event occurred Oct 10, 2024

Report 1051526-2024-00002 · MDR key 20674340

Device

Generic name

Redemption Duo Distal Targeting Frame

Manufacturer

Vilex, Llc

Model number

RD-TARG-DT

Catalog number

RD-TARG-DT

Lot number

O5029

Product problems

Inadequate Instructions for Healthcare Professional
Material Separation
Detachment of Device or Device Component
Device Damaged by Another Device
Inadequate Instructions for Healthcare Professional
Material Separation
Detachment of Device or Device Component
Device Damaged by Another Device

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

SALES REPRESENTATIVE NOTIFIED VILEX ON 10/14/2024 OF INSTRUMENTATION MALFUNCTIONS THAT OCCURRED DURING A LOWER EXTREMITY CHARCOT REVISION PROCEDURE. THE FOLLOWING INFORMATION WAS FURTHER PROVIDED BY THE SALES REP ON 10/21/2024: THE TARGETING GUIDE EXTENDER LOCKED INTO PLACE AND LOCKING CAMS FELL OFF WHILE INSERTING THE NAIL WITH THE MALLET; THE INSERTION TOOL ADHERED TO THE BOTTOM OF THE TARGETING GUIDE; TARGETING GUIDE HEEL CUP DETACHED FROM INTERNAL COMPONENT AS IT WAS BEING ATTACHED TO THE GUIDE ASSEMBLY. VILEX WAS MADE AWARE ON 10/24/2024 OF ADDITIONAL EMDRS SUBMITTED BY THE FACILITY REGARDING THE SAME EVENT. REPORT NO. (B)(4).