GAMMA 1420-2100Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07613327591477), received between May 6, 2024 and Sep 1, 2026 — classified as 3 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (16 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2026Failure to Align

  As reported: "On the (b)(6)2026 a G4 Intermediate Nail has been used at (b)(6). The distal locking screw through the Gamma4 targeted jig missed the nail. This was believed to be corrected at the time by re-attaching the jig and checking on Xray. However, at a follow up Xray the screw has appeared to miss posteriorly compared to it previously missing anteriorly. This resulted in the patient coming back to theatre on the (b)(6)2026 to have another distal screw inserted through the nail."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50550090 ↗
• InjuryAug 25, 2026Failure to Align

  As reported: "On the (b)(6)2026 a G4 Intermediate Nail has been used at (b)(6) Hospital. This case was covered by (b)(6). The distal locking screw through the Gamma4 targeted jig missed the nail. This was believed to be corrected at the time by re-attaching the jig and checking on Xray. However, at a follow up Xray the screw has appeared to miss posteriorly compared to it previously missing anteriorly. This resulted in the patient coming back to theatre on the (b)(6)2026 to have another distal screw inserted through the nail. The jig was re-attached and again when drilling through the intermediate jig the drill was hitting the nail and not aligning with the locking screw hole. The surgeon Mateo managed to get a screw through the oblique hole of the intermediate nail and tried again through the static locking. The issue was raised that he believes there may be some issues with the jig itself or the nail screw holes not aligning with the jig correctly if 1 screw is able to pass through but not the other."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50440232 ↗
• MalfunctionMay 22, 2026Failure to Align

  IT WAS REPORTED: "THE GAMMA4 TARGETER HAS CONTINUOUSLY BEEN MISSING THE DISTAL SCREWS OF THE NAIL ON INTERMEDIATE NAILS.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25255471 ↗
• MalfunctionApr 28, 2026Failure to Align

  AS REPORTED: "THE GAMMA4 INTERMEDIATE NAIL WAS USED. DURING DRILLING FOR DISTAL LOCKING SCREW INSERTION, INTERFERENCE BETWEEN THE DRILL BIT AND THE NAIL WAS OBSERVED. DESPITE COMPLETING DRILLING TO THE CONTRALATERAL CORTEX AFTER MINOR ADJUSTMENT, ORBITING OCCURRED DURING SCREW INSERTION, RESULTING IN FAILURE TO INSERT ONE OF THE TWO DISTAL LOCKING SCREWS. DURING INSERTION OF THE DISTAL LOCKING SCREW, MISALIGNMENT FROM THE INTENDED POSITION OCCURRED, POTENTIALLY CAUSING UNNECESSARY ADDITIONAL BONE/TISSUE TRAUMA TO THE PATIENT."

  Patient problems: Perforation

  MAUDE report 25018880 ↗
• MalfunctionMar 30, 2026Failure to Align

  AS REPORTED: "TARGET DIDN'T MATCH ON TWO HOLES."

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

  MAUDE report 24715597 ↗
• MalfunctionMar 10, 2026Failure to Align

  AS REPORTED: "DURING THE PRE-DRILLING INTERFERENCE CHECK, THE DRILL BIT WAS FOUND TO HAVE SLIGHT INTERFERENCE WITH THE DISTAL LATERAL STOP HOLE. IT WAS USED AS IS, AND DURING DRILLING, THE BIT DEVIATED FROM THE HOLE, SO DRILLING WAS PERFORMED WHILE HOLDING THE SLEEVE. THE PRIMARY COMPLAINT IS THAT THE INTERMEDIATE TARGETING SLEEVE FELT STIFF DURING USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560505 ↗
• MalfunctionJan 30, 2026Labelling, Instructions for Use or Training Problem; Failure to Align

  IT WAS REPORTED: "JIG FAILED TO TARGET DISTAL HOLES IN GAMMA NAIL. JIG DOES NOT SMOOTHLY SLIDE ON GAMMA NAILING TARGET. SEEMS TO NOT LOCK PROPERLY, LEAD TO MISSDRILLING. AFTER THE CASE, USED A SAMPLE NAIL, TRIPLE SLEEVES AND DETERMINED LOCKING KNOB MAY BE DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222626 ↗
• MalfunctionDec 17, 2025Failure to Align; Failure to Align

  AS REPORTED: "OUT OF BONE DURING DRILLING IN THE DISTAL DYNAMIC HOLE. RETRIED WITH THE DEVICE AND THE PROCEDURE WAS COMPLETED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23834446 ↗
• MalfunctionNov 19, 2025Failure to Align; Failure to Align

  AS REPORTED: "TODAY ON THE BACK TABLE AT (B)(6) HOSPITAL IT WAS NOTICED THAT THE INTERMEDIATE JIG WAS MIS FIRING THE DISTAL LOCKING SCREW. THIS CAUSED A 5-10 MINUTE DELAY TO FETCH A NEW JIG.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23598579 ↗
• MalfunctionNov 17, 2025Failure to Align; Failure to Align

  AS REPORTED: "DISTAL DRILL INTERFERED WITH THE NAIL AND COULD NOT DRILL INTO THE NAIL EASILY. THE PHYSICIAN COULD DRILL WITH DIFFICULTY WHILE HAVING THE SLEEVE CONTROLLED BY FINGERS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23574286 ↗
• MalfunctionApr 28, 2025Failure to Align; Failure to Align

  AS REPORTED: "MISS-TARGET OCCURRED WHILE DRILLING INTO THE DISTAL OVAL HOLE OF THE GAMMA4 IM NAIL. THE PRIOR DRILLING INTO THE TRUE CIRCLE HOLE WAS SUCCESSFUL. THE DRILLING WAS COMPLETED WITH MANUAL RECOVERY AND THE SCREW WAS ALSO INSERTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918715 ↗
• MalfunctionApr 16, 2025Failure to Align; Failure to Align

  AS REPORTED: "BEFORE INSERTING THE NAIL, THE G4 INTERMEDIATE DEVICE WAS ATTACHED TO THE MAIN TARGETING DEVICE, AND WHEN CHECKING TO SEE IF THE DRILL TIP WOULD PASS THROUGH THE NAIL CORRECTLY, IT WAS DISCOVERED THAT THE DRILL WOULD INTERFERE WITH THE NAIL. THERE WAS NO ALTERNATIVE DEVICE. WITH THE DEVICE LOCK LOOSENED, THE DOCTOR PERFORMED THE DRILLING AND SCREW INSERTION, AND THE OPERATION WAS COMPLETED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21847516 ↗
• InjuryOct 16, 2024Failure to Align; Failure to Align

  IT WAS REPORTED THAT WHEN USING A GAMMA 4 INTERMEDIATING NAIL IN A HIP FRACTURE TREATMENT SURGERY, MISDRILLING OCCURRED USING TARGET SLEEVE FOR GAMMA 4 INTERMEDIATE NAIL. A MISDRILL RESULTED IN A DRILL HOLE IN THE FEMUR AND AS A RESULT, THE LOCKING SCREW COULD NOT BE INSERTED.

  Patient problems: Insufficient Information; Perforation

  MAUDE report 20465876 ↗
• MalfunctionOct 14, 2024Failure to Align; Failure to Align

  AS REPORTED: "THE SURGEON MISSED WITH INTERMEDIATE TARGETING SLEEVE FOR A GAMMA 4 INTERMEDIATE NAIL. THE ALPHA 4.2X360MM DRILL HIT THE NAIL AND WOULD NOT PASS THROUGH THE DYNAMIC HOLE. AS THE SURGEON GRADUALLY TRIED TO FIND HIS POSITION THE DRILL SKIVED POSTERIOR TO THE NAIL. IN THE AP IT APPEARED TO HAVE MADE IT THROUGH THE HOLE. ON THE LATERAL THE SCREW WAS POSTERIOR. THE SURGEON LOCKED PROXIMALLY TO THE DYNAMIC HOLE USING THE INTERMEDIATE TARGETING SLEEVE AND PASSED THROUGH THE NAIL WITHOUT ANY ISSUES. WE LOCKED THE PROXIMAL STATIC HOLE AND LEFT THE DISTAL DYNAMIC HOLE OPEN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441032 ↗
• MalfunctionAug 15, 2024Break; Positioning Failure; Fracture; Break; Positioning Failure; Fracture

  IT WAS REPORTED: WHEN TARGETING ACCURACY WAS CHECKED PRIOR TO NAIL INSERTION, THE DRILL DID NOT PASS THROUGH THE DISTAL HOLE OF THE NAIL AND CONTACTED THE ANTERIOR OF THE NAIL. WHEN THE NAIL WAS REPLACED AND CHECKED AGAIN, THE DRILL MADE CONTACT WITH THE ANTERIOR OF THE NAIL AS WELL. SO, THE SURGEON SWITCHED TO USING OTHER SYSTEMS.

  Patient problems: Insufficient Information

  MAUDE report 19997393 ↗
• MalfunctionAug 2, 2024Failure to Align; Positioning Problem; Failure to Align; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT HAD A FRACTURED PROXIMAL FEMUR. THE GAMMA 4 SLEEVE'S BUTTON HAD POPPED OUT AND WAS NOT LOCKING IN, AND THE INTERMEDIATE SLEEVE WAS NOT ALIGNING PROPERLY WITH THE NAIL. A SECOND SET WAS OPENED TO COMPLETE THE SURGERY, ADDING 10-15 MINUTES TO THE PROCEDURE. A SECOND SET WAS USED TO COMPLETE THE CASE AND NO ISSUES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19900272 ↗
• MalfunctionJul 29, 2024Positioning Failure; Positioning Failure

  MISS-DRILL WAS OCCURRED USING TARGET DEVICE. THE SURGEON HAD DIFFICULTY WITH DRILLING, BUT COMPLETED THE PROCEDURE WITH MANUAL ADJUSTMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19850405 ↗
• MalfunctionJul 9, 2024Positioning Failure; Failure to Align; Positioning Failure; Failure to Align

  BOTH DISTAL LATERAL DRILLS WERE MISSED THROUGH THE DEVICE. THE SURGEON MANAGED TO RECOVER AND INSERT THE SCREWS BY CORRECTING THE POSITION OF THE SLEEVES WHILE DRILLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19703018 ↗
• MalfunctionMay 6, 2024Positioning Failure; Positioning Failure

  AS REPORTED: "A GAMMA4 INTERMEDIATE NAIL WAS DRILLED OVER THE DISTAL DEVICE, BUT WAS DISLODGED AND THE SCREW COULD NOT BE INSERTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19256478 ↗