PIVOT GUARDIAN, FRAME

Description of Event or Problem

IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED DUE TO THE DEVICE NOT BEING ABLE TO HOLD TRACTION. PLEASE NOTE, NO INCISIONS WERE MADE PRIOR TO CANCELLING THE PROCEDURE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.

Additional Manufacturer Narrative

THE DEVICE MANUFACTURER DATE IS NOT KNOWN. THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. ALLEGED FAILURE: UNABLE TO HOLD TRACTION PROBABLE ROOT CAUSE: DESIGN: * CONSTRUCT DESIGN (VERTICAL AND HORIZONTAL SPARS, BASE, FINE TRACTION) * VERTICAL SPAR DOESN'T GLIDE WELL OR GETS JAMMED ON HORIZONTAL SPAR RAIL * CABLE IN VERTICAL SPAR IS PINCHED BY HIGH TRACTION FORCES CAUSING BENDING IN THE VERTICAL SPAR * FINE TRACTION ELEMENT LEVER STICKS OR GETS JAMMED WITH HIGH TENSION FORCE * GROSS TRACTION LOCK JAMS UNDER HIGH TENSION -BASE SLIPS UNDER HIGH TENSION PROCESS: - VERTICAL AND HORIZONTAL SPAR ARE NOT CALIBRATED CORRECTLY TO BE COMPATIBLE TO EACH OTHER OR INTERCHANGEABLE WITH OTHER SPARS. APPLICATION: - INSUFFICIENT FRICTION BETWEEN PATIENT AND THE SURGICAL TABLE OR PATIENT AND THE POSITIONING PAD (OR TABLE AND THE POSITIONING PAD) USE ERROR H3 OTHER TEXT : 81.

Description of Event or Problem

IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED DUE TO THE DEVICE NOT BEING ABLE TO HOLD TRACTION. PLEASE NOTE, NO INCISIONS WERE MADE PRIOR TO CANCELLING THE PROCEDURE.