MalfunctionKGS

BIO-PUSH LOCK

Received Jul 24, 2007 · Event occurred Jul 13, 2007

Report 903464 · MDR key 903464

Device

Generic name

Anchor, Suture, Arthroscopic

Manufacturer

Arthrex Arthroscopy Instruments, Inc.

Model number

Catalog number

AR-1926B

Lot number

124287

Product problems

Break
Difficult to Insert
Device, removal of (non-implant)

Patient

49 YR

Foreign body, removal of

Narrative

Description of Event or Problem

THE DEVICE BROKE IN THE PATIENT'S RIGHT SHOULDER WHILE IT WAS BEING IMPLANTED INTO THE GLENOID. THE LOOSE PIECES WERE RETRIEVED AND REMOVED ARTHROSCOPICALLY IN CONJUNCTION WITH THE SCHEDULED PROCEDURE.