inforMED
InjuryHXK

SYMMETRY MAYO CLASSIC®

Received Jul 15, 2025 · Event occurred May 19, 2025

Report 22505785 · MDR key 22505785

Device

Generic name

Holder, Needle; Orthopedic

Model number

36-2017

Catalog number

36-2017

Lot number

31081195

Product problems

  • Break
  • Entrapment of Device

Patient

67 YR · Female

  • Foreign Body In Patient
  • Foreign Body In Patient

Narrative

Description of Event or Problem

A NEEDLE DRIVER WAS FOUND IN STERILE PROCESSING TO BE MISSING A LAYER OF THE INNER TIP. THE INSTRUMENT WAS PULLED FROM SERVICE. THE QUALITY ASSURANCE TEAM CONNECTED AND CONFIRMED THE RESULTS OF THE PATHOLOGY SPECIMEN, A 1 MM X ~2 MM METALLIC FLAKE OF A TEXTURED GRIPPING SURFACE, TO THE SEQUESTERED NEEDLE DRIVER. THIS METAL FLECK WAS IN THE PATIENT IN THE WOUND, FOUND ON ROUTINE POST OPERATIVE XRAY, LIKELY BROKE OFF DURING SUTURING/CLOSING THE WOUND. THE NEEDLE DRIVER/HOLDER WAS STILL FUNCTIONAL, AND THE BROKEN OFF FLECK WAS SO SMALL, IT WAS NOT IDENTIFIED AT TIME OF USE ON THE PATIENT. THE PATIENT DID RETURN TO THE OR FOR REMOVAL OF THE FOREIGN OBJECT.