inforMED
MalfunctionGDF

SURGICAL NEEDLE HOLDER

Received Jul 18, 2019 · Event occurred Jul 12, 2019

Report MW5088239 · MDR key 8807582

Device

Generic name

Guide, Needle, Surgical

Product problems

  • Material Separation
  • Device Fell

Patient

Not reported

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

Narrative

Description of Event or Problem

WHEN CLEANING INSTRUMENTS THAT HAD JUST BEEN USED IN A SURGICAL CASE, A LION JAW INSERT SEPARATED AND FELL OFF A NEEDLE HOLDER. THE PIECE THAT FELL OFF IS SMALL; 1.2 CM LONG X 0.2CM WIDE. THIS COULD'VE FALLEN INTO THE SURGICAL WOUND UNNOTICED. I CONSIDER THIS A NEAR-MISS. FDA SAFETY REPORT ID# (B)(4).