SYMMETRY MAYO CLASSIC®
Received Jul 15, 2025 · Event occurred May 19, 2025
Report 22505785 · MDR key 22505785
Device
Generic name
Holder, Needle; Orthopedic
Manufacturer
Symmetry Surgical Inc.Model number
36-2017Catalog 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.