Hana/ProFx Traction Boot XLarge (pr) 6850-487Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842430106491), received between May 25, 2018 and May 25, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Misassembled” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2018Detachment Of Device Component; Detachment of Device or Device Component; Component Misassembled; Detachment Of Device Component; Detachment of Device or Device Component; Component Misassembled

  IT WAS REPORTED THE CUSTOMER WAS USING THE HANA TABLE FOR A ANTERIOR HIP REPLACEMENT CASE. WHEN THE RN IN THE ROOM PULLED TRACTION FOR THE SURGEON DURING THE CASE, THE ALLEN SCREW THAT WAS HOLDING THE BASE PLATE TO THE BOOT BROKE APART, AND THE BOOT WAS LEFT SWINGING WITH THE PATIENT'S FOOT STILL ATTACHED IN BOOT. NURSE WENT UNDER THE DRAPES TO SECURE THE PATIENTS FOOT AND IMMEDIATELY CHANGED THE BOOT ON THE PATIENT'S FOOT. WE NOTICED AFTER THE CASE THAT THE BOOT WAS INCORRECTLY MANUFACTURED WITH TWO WASHERS PLACED ON THE BOOT AND NOT ALLOWING THE ALLEN SCREW ENOUGH THREADS TO HOLD THE WEIGHT PLACED UPON IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7544879 ↗