inforMED
MalfunctionDZH

SAGGITAL SAW BLADE PRECISION THIN OFFSET

Received Apr 19, 2017 · Event occurred Apr 17, 2017

Report 6503013 · MDR key 6503013

Device

Generic name

Saw, Bone, Ac-powered

Manufacturer

Stryker Corp

Model number

2296-003-511

Catalog number

2296-003-511

Lot number

17026017

Product problems

  • Break
  • Noise, Audible

Patient

23 YR

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

Narrative

Description of Event or Problem

SURGEON WAS SAWING AND SURGICAL SCRUB TECH NOTICED THAT THE SAW WAS "SOUNDING" WEIRD. ORIGINALLY THOUGHT IT WAS THE BATTERY AND INSPECTED SAW AND REALIZED THAT THE BLADE WAS BROKEN. REMOVED BLADE AND THERE WAS A PIECE MISSING. TEAM WAS USING C-ARM AT THE TIME AND SHOTS WERE TAKEN; NO EVIDENCE OF PIECE IN SURGICAL SITE. PORTABLE XRAY WAS TAKEN AT END OF CASE AND READ NEGATIVE FOR FOREIGN BODY.