OMEGA 3362-5-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327092882), received between Jan 18, 2018 and Jan 21, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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.

• MalfunctionJan 21, 2020Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  AS REPORTED: "THE OMEGA 3 SYSTEM WAS CHOSEN TO PROVIDE FIXATION OF AN INTERTROCHANTERIC FRACTURE ON A MALE TRAUMA PATIENT OF UNKNOWN AGE. THE OMEGA 135° GUIDE WAS USED TO INSERT THE OMEGA GUIDE PIN. OMEGA REAMER AND OMEGA TAP WERE USED BEFORE INSERTION OF LAG SCREW. AN OMEGA 3 LAG SCREW (95MM) WAS IMPLANTED OVER THE OMEGA GUIDE PIN. THE SURGEON DECIDED TO EXCHANGE IT FOR A LONGER LAG SCREW. THE REAR PART (SCREW/ DRIVER INTERFACE) OF THE 95MM LAG SCREW WAS VISUALLY DEFORMED AFTER EXTRACTION. AN OMEGA 3 LAG SCREW (105MM) WAS THEN INSERTED OVER THE GUIDE WIRE. DURING INSERTION, THE DISTAL (REAR) PART OF THE SCREW BEGAN TO DEFORM (AT THE SCREW/ DRIVER INTERFACE). THE DEFORMATION WAS VISUALIZED BY THE SURGEON. THE SURGEON ATTEMPTED TO INSTALL THE OMEGA 3 STABILIZATION PLATE ONTO THE LAG SCREW WITHOUT SUCCESS. THE LAG SCREW SCREWDRIVER WAS NOT ABLE TO REMOVE THE DAMAGED LAG SCREW. A CONICAL EXTRACTOR WAS USED TO SUCCESSFULLY REMOVE THE LAG SCREW. A NEW OMEGA 3 LAG SCREW (100MM) WAS THEN INSERTED OVER THE GUIDE WIRE. THE OMEGA STABILIZATION PLATE DID NOT FIT THE BONE TO THE SURGEON'S LIKING AND WAS REPLACED WITH AN OMEGA SHORT BARREL HIP PLATE 135°, 2 HOLE. X (4.5 X 40MM) SCREWS WERE INSE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9614116 ↗
• MalfunctionJun 24, 2019Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE LAG SCREW SHEARED OFF IN THE INSERTION DEVICE. NO ADVERSE CONSEQUENCE OR SURGICAL DELAY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8729117 ↗
• MalfunctionMar 26, 2019Break; Fracture; Fracture

  THE 'TEETH'AT THE BASE OF THE OMEGA LAG SCREW SHEARED OFF DURING INSERTION WITH THE 'ONE PIECE LAG SCREW INSERTER (- 704047), WHICH WAS ALSO DAMAGED. THIS WAS IDENTIFIED DURING THE PROCEDURE, AND UPON INSPECTION POST PROCEDURE, THE ISSUE WAS IDENTIFIED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8452788 ↗
• MalfunctionFeb 15, 2019Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT OMEGA3 DYNAMIC HIP SCREW SYSTEM WAS USED YESTERDAY. AS HE WAS PUTTING THE LAG SCREW IN, THE DISTAL END OF THE SCREW DEFORMED & HE WAS UNABLE TO REMOVE THE SCREW AFTER THIS AS THE LAG SCREWDRIVER WOULD NO LONGER ATTACH TO THE LAG SCREW. 60 MINUTE SURGICAL DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 8343116 ↗
• MalfunctionJan 18, 2018Mechanical Problem

  WHILE INSERTING AN OMEGA3, 4 HOLE PLATE AND 105MM LAG SCREW, THE SURGEON STRUGGLED TO GET THE PLATE TO SLIDE OVER THE LAG SCREW. UPON CLOSER INSPECTION THE SURGEON NOTICED THAT THE TABS ON THE LAG SCREW HAD SHEARED OFF DURING FINAL INSERTION. THE OP TECH HAD BEEN FOLLOWED, LAG SCREW WAS DRILLED AND TAPPED PRIOR TO INSERTION.

  Patient problems: No Information

  MAUDE report 7203667 ↗

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