Screw tension device 10033700Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046768000247), received between Apr 5, 2024 and Apr 5, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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.

• MalfunctionApr 5, 2024Crack; Detachment of Device or Device Component; Unintended Movement; Crack; Detachment of Device or Device Component; Unintended Movement

  ON 26TH FEBRUARY 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - (B)(6) - SCREW TENSION DEVICE USED WITH 141901JC - EXTENSION DEVICE. AS IT WAS STATED AND CONFIRMED WITH THE PHOTOGRAPHIC EVIDENCE, CRACKS IN SCREW FIXING PARTS OF THE HOUSING WERE DISCOVERED. ON (B)(6) 2024, ADDITIONAL INFORMATION WAS PROVIDED. IT HAS BEEN CONFIRMED THAT THE ISSUE OCCURRED DURING HIP JOINT DISPLACEMENT SURGERY ON AN ANESTHETIZED PATIENT. AS IT WAS STATED, THE ACCESSORY DETACHED COMPLETELY LEADING TO SLOW CHANGE IN PATIENT POSITION THAT WAS UNDER STAFF CONTROL. THE ISSUE RESULTED IN A DELAY IN PROCEDURE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATIONS, NAMELY THE DETACHMENT OF THE ACCESSORY LEADING TO CHANGE IN THE PATIENT POSITION AND DELAY IN SURGERY RESULTING IN PROLONGED ANESTHESIA TIME, WERE TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19048417 ↗