Innomed, Inc. 1769Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840277117304), received between Dec 30, 2015 and Dec 30, 2015 — classified as 1 malfunction.

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

• MalfunctionDec 30, 2015Break

  CUSTOMER ((B)(6) HEALTH) REPORTED THAT THE TOOTH OF THE SOUDRY LOOSE TISSUE GRASPER BROKE OFF WHILE IN USE AND IS INSIDE THE PATIENT. AN ADDITIONAL PART NUMBER, PURCHASED AT THE SAME TIME WAS SUBJECTED TO PRESSURE. ITS TOOTH ALSO BECAME LOOSE. ONCE RECEIVED AT INNOMED, THE ITEMS WERE VISUALLY INSPECTED TO CHECK THE SECURITY OF THE TOOTH PIN AND NO FAULTS WERE FOUND. THE TOOTH WELD DID NOT HAVE ANY CRACKS AND THE POLISHED SIDE HAD SUFFICIENT MATERIAL TO PRESERVE THE SECURITY OF THE PIN. ALTHOUGH NO ISSUES WERE IDENTIFIED WITH THE TOOTH PIN'S SECURITY, IT WAS DETERMINED THAT THE ITEMS WOULD BE FORWARDED TO THE VENDOR TO HAVE THE NEW WELD PROCESS APPLIED. THE ITEM WAS RECEIVED AND SUBJECTED TO VISUAL INSPECTION. NO ISSUES WERE IDENTIFIED. THE INTENDED USE OF THE SOUDRY LOOSE BODY GRASPER IS TO AID IN THE REMOVAL OF SOFT TISSUE LOOSE BODIES IN ARTHROSCOPY AND OPEN PROCEDURES. THE INSTRUMENT WAS TESTED BY APPLYING IT ON VARIOUS TYPE RUBBERS, FOAM AND CARDBOARD TO SIMULATE THE REMOVAL OF SOFT TISSUE. NO BREAK IN THE WELD WAS EXPERIENCED WHEN USED TO GRIP, PULL, AND TWIST THE MATERIAL . THE INSTRUMENT WAS ALSO TESTED BY APPLYING IT TO METAL AND WOOD TO SIMULATE REMOVAL OF HARD TISSUE. IT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5335581 ↗