MalfunctionGZX

AVALIGN

Received Dec 6, 2024 · Event occurred Nov 4, 2024

Report 1421101-2024-00006 · MDR key 20863290

Device

Generic name

Kray Hook With Finger Ret Large Ball Tip Tip 3.5mm Ol 185 (7 1/4")

Manufacturer

Avalign Technologies Inc.

Model number

VM82-7222

Lot number

04012

Product problems

Material Fragmentation
Material Fragmentation

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

ON 11/06/2024, AVALIGN GSI QUALITY RECEIVED A CUSTOMER COMPLAINT FROM STERIS CORPORATION. STERIS CORP REPORTED THAT THEIR CUSTOMER, THE NEBRASKA MEDICAL CENTER,REPORTED TO THEM THAT THEY HAD TWO (2) UNITS OF CUSTOMER PART# VM82-7222 THAT THE BALL TIPS BROKE OFF DURING A CASE. THEY WERE REMOVED WITH NO PATIENT IMPACT.