GAMMA 1320-0111Recalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 04546540716774), received between Aug 18, 2015 and Sep 16, 2026 — classified as 2 injuries, 97 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (59 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 99 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Failure to Align

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793055 ↗
• MalfunctionMay 19, 2026Failure to Align

  WHILE DRILLING FOR THE DISTAL LOCKING SCREWS, THE DRILL BIT WENT OFF COURSE DUE TO THE GAMMA3 GUIDE. ACCORDING TO THE CUSTOMER, THE CORRECT GUIDE SLEEVE FOR THE SELECTED IMPLANT WAS USED. REPLACEMENT WAS AVAILABLE. ADDITIONAL INFORMATION: IT WAS NOT THE DISTAL LOCKING SCREW THAT WAS THE PROBLEM. THE PROBLEM WAS THE LAG SCREW STEP DRILL. THE LAG SCREW REAMER DIDN¿T HIT THE HOLE IN THE NAIL. THE CUSTOMER USED THE CORRECT G3 TARGETING SLEEVE FOR THE NAIL. THE SETUP WAS CHECKED TWICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25217662 ↗
• MalfunctionMar 30, 2026Failure to Align

  AS REPORTED: "TARGET DRILLING HOLES ARE NOT CENTERED IN THE FIXTURES. REPLACEMENT WAS AVAILABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715584 ↗
• MalfunctionMar 30, 2026Failure to Align; Material Twisted/Bent

  AS REPORTED: "DURING THE ATTEMPT TO PLACE THE DISTAL LOCKING SCREW OF THE GAMMA 3 NAIL, TWO DRILL BITS BROKE BECAUSE DRILLING OCCURRED ONTO THE NAIL. THE TARGETING ARM AND SLEEVE BECAME BENT. THE MEDICAL TREATMENT COULD BE COMPLETED BECAUSE REPLACEMENT INSTRUMENTS WERE AVAILABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24710593 ↗
• MalfunctionMar 5, 2026Device Difficult to Setup or Prepare

  AS REPORTED: "TOO MUCH FORCE IS REQUIRED WHEN ASSEMBLING THE NAIL WITH THE GAMMA3 TARGETING DEVICE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523945 ↗
• MalfunctionFeb 9, 2026Material Erosion

  AS REPORTED: "DURING THE CONFIRMATION OF TARGET ACCURACY, BLACK DEBRIS WAS FOUND COMING FROM INSIDE THE DEVICE. THE PATIENT WAS UNDER GENERAL ANESTHESIA PRIOR TO SKIN CUT, BUT THE PROCEDURE WAS POSTPONED TO THE FOLLOWING DAY."

  Patient problems: Insufficient Information

  MAUDE report 24299502 ↗
• MalfunctionDec 18, 2025Mechanical Jam; Mechanical Jam

  AS REPORTED: "THE TARGET DEVICE CANNOT BE DETACHED FROM THE IMPLANT. THE NAIL WAS COMPLETELY IMPLANTED, INCLUDING PROXIMAL AND DISTAL LOCKING. THE TARGET BAR COULD NO LONGER BE DISCONNECTED VIA THE NAIL RETAINING SCREW, SO AN ATTEMPT WAS MADE TO REMOVE THE DISTAL LOCKING. HOWEVER, THE TARGET BAR WAS IN THE WAY, SO AN ATTEMPT WAS MADE TO SHORTEN IT USING A SAW. ULTIMATELY, THE BAR AND NAIL WERE REMOVED USING A HAMMER. REPLACEMENT WAS AVAILABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839543 ↗
• MalfunctionDec 1, 2025Failure to Align; Failure to Align

  AS REPORTED: "WHEN AIMING, THE K-WIRE SOMETIMES TOUCHES THE NAIL; WHEN DRILLING, METAL CONTACT CAN BE FELT. THE PROCEDURE WAS COMPLETED WITH THE USE OF A SECOND DEVICE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680312 ↗
• MalfunctionOct 16, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT: "A GAMMA 3 NAIL THAT GOT STUCK IN THE NAIL HOLDER.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23315028 ↗
• MalfunctionAug 12, 2025Failure to Align; Failure to Align

  AS REPORTED: "DRILLED NEXT TO THE NAIL FOR DIST. LOCKING. PROCEDURE COMPLETED MANUALLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22787734 ↗
• MalfunctionMay 8, 2025Mechanical Jam; Mechanical Jam

  AS REPORTED: "IMPOSSIBLE TO REMOVE THE NAIL-HOLDER BOLT AND THEREFORE THE NAIL-HOLDER FROM THE NAIL. OBLIGED TO REMOVE THE NAIL MOUNTED ON THE NAIL HOLDER AND REPEAT THE OP WITH ANOTHER GAMMA3 ANCILLARY. CHANGE ANCILLARY AND IMPLANT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21985734 ↗
• MalfunctionMar 26, 2025Failure to Align; Failure to Align

  AS REPORTED: "CARBON TARGET DEVICE G3 WAS MALFUNCTIONING FOR DISTAL TARGETED SCREWS. DRILLING AND SCREWS WENT BESIDE THE NAIL."

  Patient problems: Insufficient Information

  MAUDE report 21700641 ↗
• MalfunctionMar 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: "METAL RING ON GAMMA3 TARGET DEVICE LOOSENED DURING SURGERY AND ENDED UP INTO PATIENT. WAS REMOVED AND SURGERY FINISHED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21608807 ↗
• MalfunctionSep 26, 2024Failure to Align; Failure to Align

  AS REPORTED: "WHEN DRILLING THE SHS AND THE DISTAL INTERLOCKING, INCORRECT DRILLING OCCURS.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20313613 ↗
• MalfunctionJul 5, 2024Failure to Align; Failure to Align

  AS REPORTED: "DISTAL LOCKING NOT POSSIBLE IN GAMMA3 SURGERY WITH AIMING SLEEVES AND INSERTION GUIDE, HOLE ABOVE SLEEVES DOES NOT MEET LOCKING HOLE OF THE IMPLANT.FREEHAND-LOCKING HAT TO BE PERFORMED TO SUCCESSFULLY COMPLETE THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19680368 ↗
• MalfunctionJun 24, 2024Failure to Align; Failure to Align

  AS REPORTED: "WHEN USING THE GAMMA3 DISTAL AIMING DEVICE, THE DISTAL HOLES OF THE NAIL WERE MISSED AFTER CORRECT ADJUSTMENT OF THE AIMING DEVICE. AFTER INSPECTION BY THE SALES REP, IT WAS DETERMINED THAT THE G3 TARGETING DEVICE AND THE DISTAL TARGETING DEVICE COULD NOT BE ADJUSTED CORRECTLY AND WERE PROBABLY WARPED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19595121 ↗
• MalfunctionFeb 21, 2024Failure to Align; Failure to Align

  AS REPORTED: "WHEN LOCKING THE SHS AND TIGHTENING THE GRUB SCREWS, MISDRILLING AND SLIPPING OFF THE SET SCREW OCCURRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18748679 ↗
• MalfunctionFeb 15, 2024Failure to Align; Material Deformation; Failure to Align; Material Deformation

  AS REPORTED: "DISTAL LOCKING OF THE GAMMA3 3125-1200S NAIL CANNOT BE LOCKED VIA TARGET ARM 1320-0111. INCORRECT DRILLING OCCURS. TARGET DEVICE IS "WARPED, MISALIGNED". "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18713165 ↗
• MalfunctionFeb 1, 2024Failure to Align; Failure to Align

  AS REPORTED BY THE REP: "THE SURGEON APPROACHED ME FOLLOWING A SHORT GAMMA3 NAIL. HE WAS DISTALLY TARGETING THE SCREWS AND AIMED FOR THE STATIC HOLE BUT THE SCREW WAS PLACED IN THE DYNAMIC POSITION AND IN HIS WORDS APPEARED TO CATCH ON THE EDGE OF THE HOLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE SCREW WENT INTO THE DYNAMIC HOLE POSITION. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18623720 ↗
• MalfunctionDec 12, 2023Mechanical Jam; Mechanical Jam

  AS REPORTED: "THE NAIL GETS STUCK IN THE TARGET DEVICE GAMMA3".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18310976 ↗
• MalfunctionDec 11, 2023Failure to Align; Failure to Align

  AS REPORTED: "THERE WERE REPEATED INCORRECT DRILLING'S IN THE LAG SCREW DRILLING OF THE GAMMA3 NAIL VIA THE AIMING BRACKET AND AIMING SLEEVE. SCREW COULD NOT BE PLACED IN G3 NAIL. OPERATION TIMES HAVE BEEN EXTENDED BY 20 MIN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18301733 ↗
• InjuryDec 6, 2023Off-Label Use; Detachment of Device or Device Component; Off-Label Use; Detachment of Device or Device Component

  AS REPORTED: "C-RING IN 1320-0111 DETACHED DURING SURGERY. NO REPLACEMENT DEVICE USED:"

  Patient problems: Foreign Body In Patient

  MAUDE report 18278430 ↗
• MalfunctionSep 22, 2023Failure to Align; Failure to Align

  IT HAS BEEN REPORTED THAT THE DEVICES CAUSE DISTAL MISDRILLING. REPLACEMENTS WERE AVAILABLE. THE PROCEDURE WAS DELAYED BY 5 MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17801470 ↗
• MalfunctionAug 4, 2023Positioning Failure; Failure to Align; Positioning Failure; Failure to Align

  AS REPORTED: "GUIDE HOLE DOES NOT MEET HOLE POSITION IN NAIL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17462041 ↗
• MalfunctionJul 25, 2023Failure to Align; Failure to Align

  AS REPORTED: "LOCKING OF THE SHORT 200 GAMMA NAIL OVER THE INSERTION GUIDE AND TARGET SLEEVE DOES NOT WORK - INCORRECT DRILLING OCCURRED. IN THE "DRY" ASSEMBLY, EVERYTHING FITS WONDERFULLY; AFTER THE NAIL HAS BEEN INSERTED ACCORDING TO INSTRUCTIONS, MISDRILLING OCCURS IN THE PROXIMAL DISTAL HOLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17392767 ↗