OMEGA 3362-5-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327092899), received between May 10, 2017 and Dec 6, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K955306); they may or may not involve this specific model.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2022Material Deformation; Material Deformation

  AS REPORTED: "OMEGA LAG SCREW TABS DEFORMED AS LAG SCREW WAS BEING INSERTED INTO PATIENT. HAD TO REMOVE & PUT IN A SHORTER SCREW. SURGEON TAPPED BEFORE INSERTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15925087 ↗
• MalfunctionAug 19, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THE OPERATING TEAM HEARD A "CRUNCH" AND NOTICED THE LABS ON THE OMEGA LAG SCREW HAD DEFORMED DURING INSERTION. SURGEON TOOK SCREW OUT AND PUT A NEW ONE IN. THE SCREW WAS NOT BENT PRIOR TO INSERTION. ONE STEP INSERTION WRENCH WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12345040 ↗
• InjuryJun 9, 2020Material Deformation; Material Deformation

  AS REPORTED: "THE END OF THE OMEGA LAG SCREW STRIPPED ON INSERTION AND IN THE SAME CASE, THE PLATE IMPACTOR SNAPPED. PLATE IMPACTOR SNAPPED DURING USE. NO REPLACEMENT WAS AVAILABLE, A BRISTOW WEDGED IN THE NOTCH WAS USED IN PLACE." ADDITIONALLY REPORTED: "A LARGER INCISION WAS NEEDED. THE PROCEDURE TOOK LONGER TO REPLACE THE LAG SCREW. 15MIN SURGICAL DELAY. IMPROVISATION WAS NEEDED TO SEAT THE PLATE ON THE BONE. A BRISTOW WEDGED IN THE NOTCH WAS USED IN PLACE." "THE LARGER INCISION WAS MADE DUE TO THE SCREW STRIPPING FIRST TRYING TO ¿HELICOPTER¿ THE SCREW AROUND USING THE PLATE AND BARREL. A LARGER INCISION WAS ALSO NEEDED BECAUSE IT WAS MORE DIFFICULT TO SEAT THE PLATE THROUGH THE TISSUE WITHOUT THE IMPACTOR."

  Patient problems: Injury

  MAUDE report 10135897 ↗
• MalfunctionJul 8, 2019Fracture; Material Deformation; Break; Fracture; Material Deformation

  THE CUSTOMER REPORTED THAT WHEN INSERTING THE LAG SCREW THE END SHEARED OFF THE INSERTER. THEY WERE ABLE TO REMOVE THE LAG SCREW. ANOTHER LAG SCREW WAS THEN INSERTED AND THE OPERATION COMPLETED. THE DHS LAG SCREW WAS INSERTED USING THE 1 STEP INSERTION TECHNIQUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8767003 ↗
• MalfunctionMay 10, 2017Difficult to Insert; Nonstandard Device; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED THAT WHEN THEY INSERTED THE LAG SCREW OVER THE GUIDEWIRE, IT DIDN'T GO OVER THE TOP AS NORMAL BUT WENT HALF DOWN AND STUCK. THE SCRUB TEAM REMOVED THE LAG SCREW FROM THE PATIENT AND TRIED A SECOND TIME. THE SAME THING HAPPENED. THE CUSTOMER REPORTED THAT IT WAS ALMOST AS IF THE SCREW HAD A PIECE OF METAL ON IT IMPEDING THE INSERTION OF THE LAG SCREW. THE CASE WAS COMPLETED BY USING A DIFFERENT LAG SCREW. THERE WAS A 5 MINUTE SURGICAL DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6557962 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K955306. One submission often covers many models, so check the product and lot details in each record.

• Z-1865-2008 · Jan 25, 2005 · Terminated
  Short Barrel Sideplate, Omega + 140 degrees, 4 slots; The Omega Plus Compression Screw system consists of a series of lag screws, proximal hip side plates, supracondylar side plate