Traction device 141901HCRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046768003811), received between Aug 13, 2024 and Aug 13, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 13, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR DEVICES - 141901HC - EXTENSION DEVICE (CODED) USED WITH 141904F0 - ADAPTER, PAIR AND 113322B4 -ALPHAMAXX (460 MM LONGIT. SHIFT), EU. AS IT WAS STATED, DURING THE RIGHT FEMORAL NECK FRACTURE SURGERY WHILE THE PATIENT'S LEG WAS FIXED AND THE GUIDE PIN WAS BEING INSERTED, A MALFUNCTION OCCURRED IN THE CONNECTION PART OF THE TRACTION DEVICE WITH THE OPERATING TABLE. CONSEQUENTLY, IT COULD NOT BE HELD AND FELL OFF. THE SURGEON QUICKLY HELD THE PATIENT; HOWEVER, THE PATIENT'S LOWER BACK WAS BENT IN A POSITION SIMILAR TO A SHRIMP'S ARCH. DUE TO THE INCIDENT, THE SURGERY WAS CANCELED AS IT WAS IMPOSSIBLE TO CHECK THE EQUIPMENT. TO CONFIRM THE HEALTH DAMAGE TO THE PATIENT, A CT SCAN WAS PERFORMED. NO HEALTH DAMAGE OTHER THAN IN THE AFFECTED AREA WAS FOUND. ON THE FOLLOWING DAY, A REOPERATION WAS PERFORMED USING ANOTHER DEVICE AND WAS SUCCESSFULLY COMPLETED. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE DETACHMENT OF THE EXTENSION DEVICE RESULTING IN A CHANGE IN THE PATIENT'S POSITION AND RESCHEDULING OF THE SURGERY, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19971009 ↗