inforMED
MalfunctionGFJ

MEAD MALLET 7-1/2 W/NYLON CAPS

Received Sep 20, 2011 · Event occurred Sep 16, 2011

Report 2274824 · MDR key 2274824

Device

Generic name

Neurosurgery Surgical Mallet

Manufacturer

Integra

Model number

19-796

Catalog number

250-415

Lot number

*

Product problems

  • Break

Patient

58 YR

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

DURING ACDF (ANTERIOR CERICAL DISKECTOMY AND FUSION), THE SURGEON WAS CHECKING THE SIZE OF SPACER NEEDED WITH TRIAL AND HANDLE. THE NYLON FACE OF THE MALLET BROKE OVER THE SURGICAL FIELD. ALL PIECES OF THE NYLON FACE WERE RETRIEVED.