inforMED
MalfunctionILZ

GARDNERER WELLS

Received Nov 15, 2016 · Event occurred Sep 30, 2016

Report 6102534 · MDR key 6102534

Device

Generic name

Accessories, Traction

Manufacturer

Zimmer, Inc.

Product problems

  • Break
  • Component Falling

Patient

Not reported

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

Narrative

Description of Event or Problem

DURING A POSTERIOR CERVICAL FUSION PROCEDURE THE SURGEON REQUESTED GARDNER WELLS TRACTION TWINE TO 16 LBS. THE TWINE IS RATED FOR MUCH MORE WEIGHT. THIS WAS THE FIRST USE FOR THE TWINE. AT THE END OF THE PROCEDURE THE TWINE BROKE AND THE WEIGHTS FELL TO THE OPERATING ROOM FLOOR. NO KNOWN HARM TO PATIENT.