inforMED
MalfunctionGEI

ARTHREX ACL TR SUTURE CUTTER

Received Sep 12, 2017 · Event occurred Aug 1, 2017

Report MW5072113 · MDR key 6861520

Device

Generic name

Electrosurgical Cutting

Manufacturer

Arthrex Gmbh

Catalog number

AR4520

Lot number

10139041

Product problems

  • Break

Patient

16 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

TIP OF ACL TR SUTURE CUTTER BROKE OFF DURING EXIT OF DEVICE FROM LEG REQUIRING SURGERY TO REMOVE THE RETAINED FOREIGN BODY.