MalfunctionMOU

SURETAC RAPID DELIVERY SYSTEM WITHOUT GLENOID GUID

Received Oct 23, 2003 · Event occurred Sep 22, 2003

Report 1219602-2003-00154 · MDR key 492044

Device

Generic name

Suretac Rapid Delivery S

Manufacturer

Smith & Nephew, Inc. Endoscopy Divis

Model number

7209818

Catalog number

7209818

Lot number

599225

Product problems

Device, or device fragments remain in patient
Replace
Tip breakage

Patient

20 YR

Surgery, prolonged
No Consequences Or Impact To Patient
Nonresorbable materials, unretrieved in body
Surgical procedure aborted/stopped

Narrative

Description of Event or Problem

DURING 'SLAP' REPAIR PROCEDURE, THE TIP OF THE GUIDEWIRE BROKE OFF IN THE PT'S BONE AND WAS NOT REMOVED. A DELAY OF 5-10 MINUTES TOOK PLACE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SURETAC DEVICE. NO PT INJURY OR COMPLICATIONS WERE NOTED.