inforMED
InjuryKGS

BIO-FASTAK SUTURE ANCHOR W/#2 FIBERWIRE

Received Aug 16, 2004

Report 1220246-2004-00069 · MDR key 539007

Device

Generic name

Suture Anchor Device

Manufacturer

Arthrex, Inc.

Model number

AR-1324BF

Catalog number

AR-1324BF

Lot number

38643

Product problems

  • Break

Patient

*

  • Nonresorbable materials, unretrieved in body

Narrative

Description of Event or Problem

IMPLANTS BROKE UPON INSERTION BUT WERE NOT RETRIEVED FROM PT. THREE PIECES FROM LOT BEING RETURNED. THIS DEVICE IS USED FOR TREATMENT.

Remedial action

  • Other