OMEGA 704001Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04546540113078), received between Mar 4, 2020 and Apr 14, 2023 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 reports).

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A CONNECTING BOLT FROM AN OMEGA 3 DHS KIT WAS BROKEN. THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 16742743 ↗
• MalfunctionMar 21, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE DEVICE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 16582166 ↗
• MalfunctionJan 23, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED: "THE SURGEON WAS USING THE IMPACTOR TO IMPACT A SIDE PLATE ONTO A LAG SCREW. ON IMPACTION, THE HANDLE CRACKED AND BROKE IN 2 PIECES. ALL DEBRIS REMOVED-LARGE PIECES." ADDITIONALLY, IT WAS REPORTED; THE PROCEDURE WAS EXTENDED HOWEVER THE LENGTH OF THE EXTENSION IS UNKNOWN. NO ADDITIONAL MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16229265 ↗
• MalfunctionDec 17, 2021Break; Break

  THE CUSTOMER REPORTED THAT THE IMPACTOR BROKE. NO DEBRIS WERE LEFT IN THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13031663 ↗
• MalfunctionApr 2, 2021Break; Break

  AS REPORTED: "OMEGA 3 PLATE IMPACTOR FAILED DURING IMPACTION OF PLATE. IT HAS FAILED BY WAY OF BREAKAGE JUST BELOW HOLES OF THE PLASTIC SECTION ABOVE WHERE IT SCREWS INTO THE METAL IMPACTOR, THIS WAS DURING ITS USE TO SEAT THE PLATE ON THE BONE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11608918 ↗
• MalfunctionMar 19, 2021Break; Break

  AS REPORTED: "OMEGA3 IMPACTOR ASSEMBLY HAS STRUCTURALLY FAILED DURING INTENDED USE. REPLACEMENT INSTRUMENT OBTAINED FROM ANOTHER CONSIGNMENT TRAY OF THE THE SAME KIT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11532243 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  AS REPORTED, "OMEGA3 PLATE IMPACTOR PLASTIC SECTION HAS BROKEN DURING USE. SURGEON SUBSTITUTED ANOTHER GENERAL ORTHO INSTRUMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10708033 ↗
• MalfunctionOct 13, 2020Fracture; Fracture

  AS REPORTED: "THE SCREW-ON ATTACHMENT (704001-1) OF THE PLATE HAMMER IS BROKEN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10672179 ↗
• MalfunctionAug 17, 2020Fracture; Fracture

  AS REPORTED: "DURING USE OF OMEGA3 PLATE IMPACTOR TO SEAT THE PLATE DURING THE OPERATIVE PROCEDURE, BLACK PLASTIC COMPONENT OF THE IMPACTOR HAS FRACTURED INTO 2 PIECES. APPROX 2 MINUTE SURGICAL DELAY."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10417636 ↗
• MalfunctionJun 23, 2020Fracture; Fracture

  AS REPORTED: BLACK PIECE OF OMEGA PLATE IMPACTOR WAS DAMAGED IN CASE WHEN BEING USED FOR IMPACTION ON PLATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10186783 ↗
• InjuryJun 9, 2020Fracture; Fracture

  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 10135894 ↗
• MalfunctionMar 16, 2020Fracture; Fracture

  THE SURGEON REPORTED THAT HE WAS DOING A DHS USING THE ONE STEP METHOD. THE HEAD OF THE LAG SCREW STRIPPED, AND WHEN IMPACTING THE PLATE THE BLACK PLASTIC PART OF THE IMPACTOR SNAPPED AT THE END OF THE SCREW THREAD. A SECOND DHS SET WAS OPENED AND THIS OCCURRED AGAIN, (PART NUMBER 704001).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9838393 ↗
• MalfunctionMar 16, 2020Fracture; Fracture

  THE SURGEON REPORTED THAT HE WAS DOING A DHS USING THE ONE STEP METHOD. THE HEAD OF THE LAG SCREW STRIPPED, AND WHEN IMPACTING THE PLATE THE BLACK PLASTIC PART OF THE IMPACTOR SNAPPED AT THE END OF THE SCREW THREAD. A SECOND DHS SET WAS OPENED AND THIS OCCURRED AGAIN, (PART NUMBER 704001).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9838341 ↗
• MalfunctionMar 4, 2020Break; Break

  THE CUSTOMER REPORTED THAT BLACK PLASTIC PART OF THE PLATE IMPACTOR ASSEMBLY BROKE DURING USE. ANOTHER TRAY WAS OPENED TO COMPLETE THE CASE. THERE WERE NO DELAYS TO SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9789398 ↗