MalfunctionKGS

ARTHREX

Received Oct 15, 2004 · Event occurred Oct 6, 2004

Report 549741 · MDR key 549741

Device

Generic name

Bio-corkscrew Suture Anchor

Manufacturer

Arthrex

Model number

Catalog number

AR-1920BF

Lot number

38598

Product problems

Break
Explanted

Patient

79 YR

Surgical procedure

Narrative

Description of Event or Problem

WHILE ATTEMPTING TO PUT ARTHREX BIO-CORKSCREW SUTURE ANCHOR IN PATIENT'S LEFT ANTERIOR TIBIALS TENDON; SUTURE ANCHOR BROKE LOOSE FROM HANDLING, DURING INSERTION.