inforMED
MalfunctionKXB

EXPEDIUM

Received Oct 11, 2019 · Event occurred Sep 18, 2019

Report 9179538 · MDR key 9179538

Device

Generic name

Probe

Manufacturer

Depuy Spine, Llc

Model number

279702030

Catalog number

279702030

Lot number

NW207194

Product problems

  • Break
  • Detachment of Device or Device Component

Patient

17520 DA

  • Device Embedded In Tissue or Plaque
  • Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

DOCTOR WAS USING THE PROBE FINDER FROM THE SYNTHES CORE 1 TRAY AND ABOUT 40MM OF THE TIP OF THE INSTRUMENT BROKE OFF IN THE PATIENT. THE SURGEON DID GET IT OUT AFTER USING SEVERAL INSTRUMENTS TO PULL IT OUT. INSTRUMENT BAGGED AND TAKEN TO QUALITY. OPERATIVE NOTE PREOPERATIVE DIAGNOSIS: LUMBAR SPONDYLOSIS. POSTOPERATIVE DIAGNOSIS: LUMBAR SPONDYLOSIS. PROCEDURES: L4-L5 POSTERIOR INSTRUMENTATION. L4-L5 POSTERIOR FUSION. PLACEMENT OF TRANSFORAMINAL LUMBAR INTERBODY GRAFT AT L4-L5. TRANSFORAMINAL LUMBAR INTERBODY FUSION L4-5. USE OF AUTOGRAFT AND ALLOGRAFT FOR SPINAL FUSION PURPOSES. USE OF INTRAOPERATIVE NEUROMONITORING AND FLUOROSCOPY. DESCRIPTION OF PROCEDURE: AT L5 ON THE RIGHT SIDE, WE ADVANCED OUR GEARSHIFT THROUGH THE PEDICLE INTO THE VERTEBRAL BODY, REMOVING THE GEARSHIFT. HER BONE BEEN EXCEPTIONALLY HARD AND I BELIEVE THE INSTRUMENT WAS SOMEWHAT AIR LOCKED. ANYWAYS, ON TWISTING AND REMOVING THE INSTRUMENT IT ACTUALLY BROKE OFF INTO THE VERTEBRAL BODY. IT TOOK A FAIR AMOUNT OF TIME IN MULTIPLE DIFFERENT INTERVENTIONS TO TRY TO GET THIS REMOVED. WE FELT THAT IT WAS CERTAINLY IMPERATIVE TO REMOVE THE INSTRUMENT FROM THE VERTEBRAL BODY. WE TRIED TO BE AS SPARING AS WE COULD WITH THE PEDICLE, SO THAT A SCREW COULD BE PLACED AFTERWARDS. IN THE END, WE DID GET THE INSTRUMENT OUT. THIS DID CORE OUT A FAIR AMOUNT OF THE SUPERFICIAL ASPECT OF THE PEDICLE. HERE WE THEN LEFT THIS WITHOUT A SCREW AND TURNED OUR ATTENTION TOWARDS THE TLIF.