MalfunctionHTW
TRANSFIX II DRILL PINS & GRAFT PASSING WIRE SET
Received Dec 2, 2005 · Event occurred Oct 24, 2005
Report 1220246-2005-00208 · MDR key 648683
Device
Generic name
Drill Pins & Graft Passing Wire Set
Manufacturer
Arthrex, Inc.Model number
AR-1978S-1Catalog number
AR-1978S-1
Lot number
72842
Product problems
- Detachment Of Device Component
- Device, or device fragments remain in patient
- Difficult to Remove
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE WIRE LOOP PULLED OUT OF THE DEVICE INSIDE THE PT. THE LOOP COULD NOT BE RETREIVED FROM THE PT, BUT NO ADVERSE CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENT. HOSP REPORTED NO PLANS FOR INTERVENTION. THIS DEVICE IS USED FOR TREATMENT.