MalfunctionGAS

ULTRA FAST-FIX

Received Nov 13, 2014 · Event occurred Nov 10, 2014

Report 4289703 · MDR key 4289703

Device

Generic name

Suture, Nonabsorbable, Synthetic, Polyester

Manufacturer

Smith & Nephew Inc.

Model number

72201494

Catalog number

72201494

Lot number

50509428

Product problems

Split
Device Operates Differently Than Expected

Patient

21 YR

No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

DOCTOR WAS PERFORMING SURGICAL PROCEDURE WHICH REQUIRED USE OF CURVED NEEDLE DELIVERY SYSTEM. AFTER THE ITEM WAS OPENED TO STERILE FIELD, THE SURGEON TESTED IT AND THE DEVICE WOULD NOT WORK PROPERLY. HE COULDN'T GET THE SUTURE TO EXPRESS FROM END OF NEEDLE. A NEW DEVICE WAS BROUGHT TO THE FIELD AND OPENED WITHOUT PROBLEM.======================MANUFACTURER RESPONSE FOR ULTRA FAST-FIX AB CURVED NEEDLE DELIVERY SYSTEM, SPLIT CANNULA, ULTRA FAST-FIX AB CURVED NEEDLE DELIVERY SYSTEM, SPLIT CANNULA (PER SITE REPORTER).======================ARRANGE TO RETURN PRODUCT.