inforMED
MalfunctionHAX

GARDNER-WELLS TONG

Received Sep 9, 2016 · Event occurred Jul 25, 2016

Report 5938789 · MDR key 5938789

Device

Generic name

Tong, Skull For Traction

Model number

66-1025

Catalog number

66-1025

Product problems

  • Device Slipped

Patient

Not reported

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

Narrative

Description of Event or Problem

THE GARDNER-WELLS TONGS WERE PLACED PER MANUFACTURER GUIDELINES. THE PROCEDURE WAS STARTED AND A SHIFT IN HEAD POSITION OCCURRED. THIS ALERTED THE STAFF THAT THE TONGS HAD ACTUALLY SLIPPED. THE SURGICAL TEAM WAS ABLE TO CONTROL THE HEAD AND MAINTAIN NECK ALIGNMENT WHILE ANOTHER SET OF TONGS WAS OBTAINED AND REAPPLIED AND ATTACHED TO TRACTION. NO FURTHER COMPLICATIONS WERE NOTED. THE STAINLESS STEEL PINIONS APPEARED TO HAVE BECOME DULLED. THIS APPEARED TO HAVE AFFECTED THE SPRING ACTION IN ONE OF THE PINS THAT SERVES AS A PRESSURE INDICATOR CAUSING THE TONGS TO SLIP ON THE SKULL. MANUFACTURER RESPONSE FOR GARDNER-WELLS TONG, SYMMETRY SURGICAL SKULL TONG (PER SITE REPORTER): THEY HAVE NO RECOMMENDATIONS.