inforMED
MalfunctionHST

PIVOT GUARDIAN

Received May 26, 2026 · Event occurred Apr 29, 2026

Report 25277472 · MDR key 25277472

Device

Generic name

Apparatus, Traction, Non-powered

Manufacturer

Stryker Endoscopy

Patient

58 YR · Male

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

UPON TRYING TO DISTRACT THE PATIENT'S HIP DURING THE START OF THE PROCEDURE, THE HIP DISTRACTOR WOULD NOT LOCK INTO PLACE TO HOLD TRACTION ON THE PATIENT'S OPERATIVE SIDE. WHEN THE PATIENT WAS NOT ON THE BED IN THE DISTRACTION BOOT, THE DISTRACTOR WAS ABLE TO LOCK AT THE START OF THE CASE PER THE STRYKER REPRESENTATIVE. MD ATTEMPTED TO DISTRACT AND LOCK THE DEVICE AS WELL WITHOUT SUCCESS. MD WAS STILL ABLE TO PERFORM THE PROCEDURE SAFELY, BUT THE NEXT CASE WAS CANCELLED DUE TO THE MALFUNCTIONING HIP DISTRACTOR.