GAMMA 1320-0310Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04546540377845), received between Apr 30, 2019 and Jun 18, 2025 — classified as 3 injuries, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  AS REPORTED: PRIMARY G3 SURGERY WAS PERFORMED ON (B)(6) 2015. THE PATIENT FELL AND RE-FRACTURED THE BONE AT UNDER THE U-LAG SCREW OF G3. REVISION SURGERY FOR REMOVING G3 AND REPLACING LONG NAIL WAS PERFORMED ON (B)(6) 2025. DURING SURGERY, THE TIP OF THE T-HANDLE BECAME BENT DUE TO THE HARDNESS OF THE BONE DURING REMOVAL. THIS RECORD COVERS THE BENT T-HANDLE.".

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287634 ↗
• MalfunctionJun 4, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "TIP OF LAG SCREW DRIVER BROKE OFF. INSTRUMENT ROTATED ON LAG SCREW. SCREW WAS COMPLETELY INSERTED INTO PATIENT. CASE TYPE: PERTROCHANTERIC FRACTURE"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22141609 ↗
• MalfunctionJul 23, 2024Positioning Failure; Mechanical Jam; Positioning Failure; Mechanical Jam

  THE THREADS OF SCREW DRIVER DID NOT HOLD THE U-LAG SCREW AND COULD NOT BE LOCKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19803986 ↗
• MalfunctionSep 15, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "WHEN SCREWING IN THE FEMORAL NECK SCREW, THE SPIKES BROKE OFF AT THE TIP. BOTH SPIKES BROKE OFF WHEN TURNED IN. IT WAS NOT DRIVEN IN WITH A HAMMER. ONE SPIKE WAS FOUND, THE OTHER WAS NOT. A SECOND TRAY HAD TO BE OPENED (ANOTHER PATIENT WAS DELAYED AS A RESULT). THIS EXTENDED THE SURGERY TIME BY ABOUT 30 MIN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17758812 ↗
• MalfunctionApr 13, 2023Break; Fracture; Material Fragmentation; Break; Fracture; Material Fragmentation

  AS REPORTED: "DURING INSERTION OF THE U-LAG SCREW, THE NECK ANGLE OF THE TARGET DEVICE WAS INCORRECTLY SET AND THE SCREW GOT STUCK IN THE NAIL, PREVENTING THE DRIVER FROM TURNING. WHEN THE SCREWDRIVER IS TURNED BY FORCE, TWO PROTRUSIONS ON THE TIP OF THE SCREWDRIVER ARE TWISTED OFF. ONE OF THE TWO FRAGMENTS WAS NOT FOUND. THE PROCEDURE WAS SWITCHED TO A REGULAR LAG SCREW, AND THE SURGERY WAS COMPLETED WITHOUT ANY OTHER PROBLEMS.".

  Patient problems: Foreign Body In Patient

  MAUDE report 16740343 ↗
• MalfunctionApr 4, 2023Break; Fracture; Material Deformation; Break; Fracture; Material Deformation

  AS REPORTED: "DURING INSERTION OF THE U-LAG SCREW, THE TIP OF THE SCREWDRIVER WAS BROKEN AND DEFORMED, AND THE SLEEVE COULD NOT BE DETACHED FROM THE SCREW DRIVER. THE SURGERY WAS FINISHED WITHOUT PROBLEM USING OTHER INSTRUMENTS AND ALL THE DEBRIS WERE REMOVED FROM THE SURGICAL FIELD/PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16673400 ↗
• MalfunctionNov 21, 2022Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  AS REPORTED: "THE TIP OF THE LAG SCREW DRIVER INNER DEFORMED WHEN ATTEMPTING TO DISLOCATE THE FEMORAL HEAD DURING GAMMA LAG SCREW EXTRACTION FOR OTHER SITE REDUCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15840761 ↗
• MalfunctionOct 11, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT WHEN REMOVING THE GAMMA 3U LAG SCREW, DUE TO A POSTOPERATIVE REFRACTURE, A U-LAG SCREWDRIVER WAS ATTACHED TO THE POSTERIOR END OF THE LAG SCREW AND AN ATTEMPT WAS MADE TO REMOVE THE SCREW, BUT THE SCREWDRIVER COULD NOT BE REMOVED. THE TIPS OF TWO SCREWDRIVERS WERE DAMAGED AS A RESULT OF EXCESSIVE FORCE. ALL DEBRIS WAS REMOVED FROM THE SURGICAL AREA. ALTHOUGH RE-FIXATION WITH T2ALPHA WAS THE FIRST CHOICE AFTER EXTRACTION, IT WAS SWITCHED TO ANOTHER COMPANY'S FEMORAL PLATE AS THE GAMMA3 NAIL WAS UNABLE TO BE EXTRACTED. IT WAS ALSO REPORTED THAT THERE WAS A 180 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15577342 ↗
• MalfunctionMay 3, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING U-LAG SCREW EXTRACTION, THE TIP OF THE DRIVER BROKE OFF. THE SURGERY WAS COMPLETED WITH THE PREPARATION OF A SUBSTITUTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14271427 ↗
• InjuryJan 12, 2022Material Deformation; Material Deformation

  AS REPORTED: "A PATIENT WHO HAD UNDERGONE SURGERY ABOUT A YEAR AND A HALF AGO WAS RE-OPERATED ON AFTER A POSTOPERATIVE PSEUDOARTHROSIS WAS IDENTIFIED. FOR REASONS UNKNOWN, A LONG GAMMA NAIL AND U-LAG SCREW WERE USED, BUT THE U-BLADE WAS NOT INSTALLED ON THE U-LAG SCREW. DURING REVISION SURGERY, WHEN REMOVING THE U-LAG SCREW, THE U-LAG SCREW DRIVER DID NOT TURN EASILY AND THE TIP WERE DEFORMED. THE SURGEON PREPARED A SUBSTITUTE AND STARTED TO REMOVE IT AGAIN, BUT THE TIP OF THE SECOND SCREWDRIVER WERE ALSO DEFORMED. EVENTUALLY, IT WAS ABLE TO BE REMOVED, BUT IT EXTENDED THE SURGERY TIME BY MORE THAN 5 HOURS."

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13236671 ↗
• InjuryJan 12, 2022Material Deformation; Material Deformation

  AS REPORTED: "A PATIENT WHO HAD UNDERGONE SURGERY ABOUT A YEAR AND A HALF AGO WAS RE-OPERATED ON AFTER A POSTOPERATIVE PSEUDOARTHROSIS WAS IDENTIFIED. FOR REASONS UNKNOWN, A LONG GAMMA NAIL AND U-LAG SCREW WERE USED, BUT THE U-BLADE WAS NOT INSTALLED ON THE U-LAG SCREW. DURING REVISION SURGERY, WHEN REMOVING THE U-LAG SCREW, THE U-LAG SCREW DRIVER DID NOT TURN EASILY AND THE TIP WERE DEFORMED. THE SURGEON PREPARED A SUBSTITUTE AND STARTED TO REMOVE IT AGAIN, BUT THE TIP OF THE SECOND SCREWDRIVER WERE ALSO DEFORMED. EVENTUALLY, IT WAS ABLE TO BE REMOVED, BUT IT EXTENDED THE SURGERY TIME BY MORE THAN 5 HOURS."

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13236656 ↗
• MalfunctionNov 23, 2021Break; Break

  THE CUSTOMER REPORTED THE FOLLOWING ISSUE: "EVENT OCCURRED AT THE HOSPITAL. AFTER THREADING IN THE RC LAG SCREW DRIVER INTO THE BACK OF THE LAG SCREW, ALREADY INSERTED IN PATIENT, (THIS WAS A REMOVAL CASE) THE TEETH AT THE END OF THE SCREWDRIVER BROKE OFF AND THE THREADED ROD INSERT WAS BENT. SCREW WAS ULTIMATELY ABLE TO BE REMOVED WITH SAME DRIVER DUE TO BEING CROSS THREADED INTO THE THREADED ROD PORTION OF THE RC LAG SCREW DRIVER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12865834 ↗
• InjuryJun 30, 2021Fracture; Fracture

  DURING GAMMA3 SURGERY, THE TIP OF THE U-LAG SCREW DRIVER BROKE. IT WAS RECOGNIZED AFTER SURGERY ON X-RAYS. THE TIP WAS LEFT IN THE PATIENT. AT THE TIME THE REPORT WAS MADE IT WAS NOTED THE REMOVAL SURGERY WOULD BE PERFORMED THE NEXT WEEK.

  Patient problems: Foreign Body In Patient

  MAUDE report 12093060 ↗
• MalfunctionNov 16, 2020Fracture; Fracture

  AS REPORTED: "A PATIENT WHO HAD INJURED IN A FALL ACCIDENT AT THE END OF LAST YEAR (DATE UNKNOWN), OPERATED WITH GAMMA NAILS AND U LAGS (LEFT SIDE) AND PERFORMED REMOVAL SURGERY. REMOVAL PROCEDURE WAS PERFORMED IN ORDER. BUT AFTER REMOVING THE SET SCREW, WHEN THE U LAG SCREWDRIVER AND THE U LAG WERE ATTACHED, AND TURNED IT COUNTERCLOCKWISE, THE TIP OF THE CLAW BROKE AND IT COULD NOT BE REMOVED. AFTER THAT, A NORMAL LUG DRIVER WAS ALSO CONNECTED, BUT THE CLAWS OF THE NORMAL LAG DRIVER ALSO BROKE, MAKING IT DIFFICULT TO REMOVE. SINCE IT TOOK TIME AND THE RISK INCREASED, THE WOUND WAS CLOSED WITHOUT REMOVING IMPLANT."

  Patient problems: Foreign Body In Patient

  MAUDE report 10848196 ↗
• MalfunctionSep 13, 2019Break; Fracture; Fracture

  AS REPORTED: "DURING INSERTING THE DISTAL PINS OF THE U-BLADE LAG SCREWDRIVER BROKE APART. NEW U-BLADE SET WAS OPENED TO COMPLETE THE PROCEDURE SUCCESSFULLY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9050523 ↗
• MalfunctionApr 30, 2019Break; Fracture; Fracture

  IT HAS BEEN REPORTED BY THE CUSTOMER THAT THE SCREWDRIVER WAS BROKEN IN THE FIRST USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8566531 ↗