GAMMA 8166-0080SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327591729), received between Oct 14, 2024 and Sep 30, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953389 ↗
• MalfunctionAug 20, 2026Positioning Failure; Material Deformation

  As reported: "An 80 mm U-Blade was inserted in an incorrect orientation and was deformed after being impacted with a hammer. The deformed U-Blade was removed and replaced with a 75 mm U-Blade. The event resulted in a prolonged procedure and extended anesthesia time."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50349877 ↗
• MalfunctionMar 9, 2026Positioning Failure

  AS REPORTED: "AFTER INSERTING THE LAG SCREW, THE SURGEON ATTEMPTED TO SECURE THE SET SCREW. SLIGHTLY BACKED OFF THE SET SCREW AND CHECKED THE LAG SCREW DRIVER. PROCEEDING WITH THE U-BLADE PROCEDURE, WHEN THE U-BLADE WAS HAMMERED IN, THE LAG SCREW ADVANCED WITH IT, PENETRATING THE HEAD OF FEMUR. TO COMPLETE THE PROCEDURE, BACKED OFF THE LAG SCREW AGAIN AND RE-SECURED THE SET SCREW."

  Patient problems: Perforation

  MAUDE report 24552214 ↗
• MalfunctionJan 22, 2026Malposition of Device; Migration

  AS REPORTED: "DURING A GAMMA NAIL OPERATION, THERE WAS POOR FIXATION OF THE LAG SCREW. ALTHOUGH A 90 MM WAS DRILLED WITH THE STEP DRILL, AN 80 MM SCREW WAS SELECTED AND INSERTED. THE SET SCREW DID NOT ENGAGE, AND WHEN INSERTING THE LAG CAP, THE LAG SCREW ADVANCED AND ROTATED. BASED ON THE SURGEON¿S JUDGMENT, IT WAS LEFT IN PLACE AND THE OPERATION WAS COMPLETED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24144978 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "THE U-BLADE WAS DIFFICULT TO INSERT, AND WHILE ATTEMPTING TO DRIVE IT IN WITH A HAMMER, THE LAG SCREW PERFORATED THE FEMORAL HEAD AND ADVANCED INTO THE ACETABULUM." THE NAIL AND LAG SCREW WERE REPLACED TO COMPLETE THE PROCEDURE.

  Patient problems: Perforation

  MAUDE report 23868632 ↗
• InjuryOct 28, 2025Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED: "PATIENT WHO UNDERWENT ORIF (GAMMA 4) AT ANOTHER HOSPITAL ON (B)(6) 2025. AT AN UNKNOWN TIME, THE LAG SCREW CUT OUT THE FEMORAL HEAD. ON (B)(6) 2025, GAMMA4 WAS REMOVED AND BHA WAS PERFORMED. PREOPERATIVE X-RAYS CONFIRMED THAT THE BLADE OF THE U-LAG SCREW WAS SIGNIFICANTLY BENT. AFTER REMOVAL, RE-EXAMINATION OF THE IMPLANT CONFIRMED THAT, AS SEEN ON X-RAY, THE BLADE WAS SIGNIFICANTLY BENT."

  Patient problems: Perforation

  MAUDE report 23404908 ↗
• MalfunctionJul 16, 2025Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  AS REPORTED: "DURING LEFT-ORIF FOR FEMORAL TROCHANTERIC FRACTURE. THE U-BLADE COULD NOT INSERTED. UPDATE JUNE 30, 2025. COULD WE GET MORE DETAILS REGARDING WHY THE U-BLADE AND WHY IT COULD NOT BE INSERTED? ARE ANY OTHER DEVICES INVOLVED? THE BLADE WAS INSERTED ACCORDING TO THE PROCEDURE MANUAL AND THE PATIENT'S BONE QUALITY WAS NORMAL, BUT THE BLADE DID NOT GO IN AT ALL. HOW WAS THE EVENT RESOLVED? THE SCREW WAS REMOVED AND A NEW LAG SCREW WAS REINSERTED TO COMPLETE THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22526839 ↗
• MalfunctionDec 5, 2024Material Deformation; Material Deformation

  AS REPORTED: USING THE GAMMA4 U-LAG SCREW 80 MM, THE SURGEON INSERTED THE U-PIN AS USUAL AND ATTEMPTED TO INSERT THE U-LAG END CAP, BUT IT WAS NOT INSERTED PROPERLY. SEVERAL ATTEMPTS WERE MADE TO INSERT THE U-LAG END CAP WHILE PUSHING IN DIFFERENT DIRECTIONS, BUT IT WAS NOT INSERTED PROPERLY. THE INSERTION OF THE END CAP WAS GIVEN UP AND DISTAL FIXATION WAS PERFORMED. AFTER CHECKING THE THREADING OF THE END CAP AND CONFIRMING THE WEAR OF THE THREADS, ANOTHER U-LAG SCREW WAS OPENED, THE END CAP WAS REPLACED. THE END CAP WAS SUCCESSFULLY INSTALLED AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20859682 ↗
• InjuryOct 14, 2024Material Deformation; Material Deformation

  AS REPORTED; "PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2024. AFTER SURGERY, IT WAS FOUND THAT FAILURE OF BLADE PORTION OF U-LAG SCREW. REVISION SURGERY WAS PERFORMED ON (B)(6) 2024".

  Patient problems: Failure of Implant

  MAUDE report 20447590 ↗