inforMED
MalfunctionLXH

EXPRESSEW NEEDLE

Received Jul 23, 2020 · Event occurred Jul 2, 2020

Report MW5095689 · MDR key 10319653

Device

Generic name

Orthopedic Manual Surgical Instrument

Manufacturer

Depuy Mitek, Inc.

Lot number

56279

Product problems

  • Break

Patient

54 YR

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

Narrative

Description of Event or Problem

TIP OF EXPRESSEW NEEDLE BROKE OFF WITHIN SHOULDER. SHOULDER WAS IRRIGATED WITH COPIOUS AMOUNTS OF NACL IRRIGATION. WOUND WAS X-RAYED AND NO REMNANTS OF DEVICE WAS VISIBLE IN WOUND. FDA SAFETY REPORT ID# (B)(4).