MalfunctionGFA

ARTHROSCOPIC SHAVER BLADE

Received May 27, 2025 · Event occurred Apr 30, 2025

Report MW5170822 · MDR key 22091210

Device

Generic name

Blade, Saw, General & Plastic Surgery, Surgical

Manufacturer

Stryker Puerto Rico, Llc.

Model number

0380-545-100

Lot number

24124CE2

Product problems

Material Fragmentation

Patient

68 YR · Male

Foreign Body In Patient
Foreign Body In Patient

Narrative

Description of Event or Problem

SURGEON WAS USING AN ARTHROSCOPIC SHAVER BLADE DURING A RIGHT KNEE ARTHROSCOPY. SURGEON NOTED TINY METAL FRAGMENTS ON THE MONITOR INSIDE THE PATIENT¿S KNEE. SURGEON DETERMINED THE METAL FRAGMENTS WERE FROM THE SHAVER BLADE. SURGEON REMOVED THE SHAVER BLADE FROM THE VETERANS¿ KNEE AND A NEW SHAVER BLADE WAS USED WITHOUT FURTHER INCIDENT. THE KNEE WAS IRRIGATED AT THE END OF THE SURGERY.