OMEGA 3362-5-095Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327093032), received between Sep 18, 2015 and Jan 21, 2020 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Bent” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2020Material Deformation; 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 9614121 ↗
• InjuryJul 12, 2019Adverse Event Without Identified Device or Use Problem

  PATIENT IN (B)(6) 2018 HAD A HIP FRACTURE AND HAD AN OMEGA PLATE/LAG SCREW AS WELL 7.2 CANNULATED SCREW. HARDWARE WAS REMOVED PRIOR TO STARTING THA PROCEDURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 8784638 ↗
• MalfunctionJun 24, 2019Entrapment of Device; Device Damaged by Another Device

  THE CUSTOMER REPORTED THAT PROBLEMS WERE ENCOUNTERED WITH THE FINAL TURN OF THE LAG SCREW INSERTER. THE BONE WAS HARD AND THE SURGEONS HAD TAPPED TO ACCOUNT FOR THIS. WHEN MEASURING FOR THE LAG SCREW THEY HAD TAKEN 5 OFF THE MEASUREMENT AND THEREFORE OVER REAMED. WHEN TRYING TO TURN THE LAG SCREW HANDLE PARALLEL TO ALLOW THE PLATE TO PASS OVER THE LAG SCREW AND SIT ONTO THE NEAR CORTEX, THE LAG SCREW IMPLANT SHEARED OFF THE INSERTION DEVICE AND BECAME BENT/TWISTED. THIS MEANT IT WAS THEN IMPOSSIBLE TO REMOVE THE LAG SCREW AND IT HAD TO BE MANIPULATED TO ALLOW THE PLATE TO PASS OVER THE TOP OF IT AND INTO PLACE. THE OPERATION WAS COMPLETED AND IT ADDED AROUND 1 HOUR TO THE OPERATING TIME. NO PIECES FELL INTO THE WOUND. THE LAG SCREW WAS ALREADY INSERTED WHEN THE ISSUE WAS DISCOVERED. THE DECISION WAS MADE THAT IT WOULD BE CLINICALLY SAFER TO LEAVE THE SCREW IN SITU RATHER THAN REMOVE IT. THE CUSTOMER REPORTED THAT THE LAG SCREW INSERTER IS FUNCTIONAL. THE PATIENT¿S BONE QUALITY WAS GOOD, HENCE THE REASON THE SURGEON TAPPED THE BONE BEFORE HE INSERTED THE LAG SCREW. THE PATIENT HAD A GENERAL ANAESTHETIC AND A REGIONAL BLOCK SO NO ADDITIONAL ANALGESIA WAS NEEDED. HOWEVER THE PATIENT W

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8729116 ↗
• MalfunctionApr 25, 2017Bent; Bent

  THE SURGEON REPORTED THAT A (B)(6) MALE, NON-SMOKER, FIT AND WELL NORMALLY WITH NO REGULAR MEDICATIONS BROKE HIS HIP FROM A BICYCLE COLLISION AT THE VELODROME. AN INTERTROCHANTERIC FRACTURE WAS SEEN ON RADIOGRAPHS AND THE PATIENT WAS IMPLANTED WITH A 4 HOLE DHS. THE SURGEON ALSO REPORTED THAT OF NOTE HIS BONE QUALITY WAS EXCELLENT. THE SURGEON REPORTED THAT ON FIRST ATTEMPT THE LAG SCREW BASE BECAME BENT AND FLANGE DEVELOPED. AND THIS PREVENTED PLATE FROM SLIDING ONTO SCREW. A SECOND SURGEON SCRUBBED IN TO RETRIEVE SCREW AND NEW SCREW INSERTED. SALES REP IS UNABLE TO SPECIFY WHICH OF THE 2 SCREWS WAS THE BENT ONE IN EACH CASE, AS THEATRE STAFF DID NOT MARK DOWN WHICH ONE WAS IMPLANTED AND WHICH ONE WAS NOT. THE ONLY INSTRUMENT USED IN CONJUNCTION WITH THE IMPLANT WAS THE ONE STEP INSERTION INSTRUMENT. NO PHOTO OF THE AFFECTED DEVICE IS AVAILABLE.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 6520544 ↗
• MalfunctionApr 25, 2017Bent

  THE SURGEON REPORTED THAT A (B)(6) MALE, NON-SMOKER, FIT AND WELL NORMALLY WITH NO REGULAR MEDICATIONS BROKE HIS HIP FROM A BICYCLE COLLISION AT THE VELODROME. AN INTERTROCHANTERIC FRACTURE WAS SEEN ON RADIOGRAPHS AND THE PATIENT WAS IMPLANTED WITH A 4 HOLE DHS. THE SURGEON ALSO REPORTED THAT OF NOTE HIS BONE QUALITY WAS EXCELLENT. THE SURGEON REPORTED THAT ON FIRST ATTEMPT THE LAG SCREW BASE BECAME BENT AND FLANGE DEVELOPED. AND THIS PREVENTED PLATE FROM SLIDING ONTO SCREW. A SECOND SURGEON SCRUBBED IN TO RETRIEVE SCREW AND NEW SCREW INSERTED. SALES REP IS UNABLE TO SPECIFY WHICH OF THE 2 SCREWS WAS THE BENT ONE IN EACH CASE, AS THEATRE STAFF DID NOT MARK DOWN WHICH ONE WAS IMPLANTED AND WHICH ONE WAS NOT. THE ONLY INSTRUMENT USED IN CONJUNCTION WITH THE IMPLANT WAS THE ONE STEP INSERTION INSTRUMENT. NO PHOTO OF THE AFFECTED DEVICE IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6520542 ↗
• InjurySep 18, 2015Device Inoperable

  THE PATIENTS FEMORAL HEAD DIED DUE TO SEVERITY OF HIS INJURY. THE OMEGA SIDE PLATE WAS REMOVER AND A TOTAL HIP ARTHROPLASTY. STRYKER RIGHT HIP WAS IMPLANTED.

  Patient problems: Injury

  MAUDE report 5088768 ↗

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