MalfunctionHXX
TITANEX
Received Mar 4, 2026 · Event occurred Feb 4, 2026
Report 1051526-2026-00002 · MDR key 24506207
Device
Generic name
Ttianex Driver T6 Cannulated
Manufacturer
Vilex, LlcModel number
ZT702-06-09Catalog number
ZT702-06-09
Lot number
208277
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING AN MIS HAMMERTOE PROCEDURE, THE JOINT WAS PREPPED AND PRE-DRILLING PERFORMED PRIOR TO SCREW INSERTION. WHILE ADVANCING THE SCREW, A SMALL SNAP WAS HEARD CAUSING THE SCREWDRIVER TO LOSE ENGAGEMENT. DRIVER TIP WAS INSPECTED AND NOTICEABLY BROKEN. A SECOND DRIVER WAS USED AND RESULTED IN THE SAME BREAKAGE. LARGER INCISION WAS MADE IN ORDER TO REMOVE THE DRIVER FRAGMENTS, TOTAL DELAY IN SURGERY EST. 45 MINUTES.
Remedial action
- Patient Monitoring