GAMMA 1420-0100Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 07613327479904), received between Jan 3, 2024 and Sep 30, 2026 — classified as 1 death, 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (22 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Align

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952918 ↗
• MalfunctionSep 28, 2026Failure to Align

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917219 ↗
• 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 25255472 ↗
• MalfunctionApr 20, 2026Failure to Align

  AS REPORTED: "GAMMA TARGETER DISTAL SCREW MISSED THE NAIL. WE DO NOT THINK THE NAIL OR SCREW IS CONTRIBUTING TO THE FAILURE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927631 ↗
• MalfunctionApr 1, 2026Mechanical Jam

  THE CUSTOMER REPORTED THAT : "THE GAMMA NAIL GOT STUCK IN ITS NAIL HOLDER. IT WAS IMPOSSIBLE TO UNSCREW IT. SEE ATTACHED PHOTOS. THE PROCEDURE HAD TO BE REPEATED, REMOVING THE CERVICAL AND DISTAL SCREWS AND THE NAIL, USING A NEW NAIL HOLDER AND NEW IMPLANTS. THE NAIL CANNOT BE SEPARATED FROM ITS NAIL HOLDER AND IS SENT FOR STERILIZATION MOUNTED ON THE NAIL HOLDER. THIS RESULTS IN WASTED TIME, A LONGER PROCEDURE, AND EXCESSIVE USE OF MATERIALS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24760355 ↗
• DeathMar 25, 2026Mechanical Jam

  AS REPORTED: "UNABLE TO UNSCREW BOLT FROM THE NAIL- TRIED EVERYTHING, HAD TO REMOVE ALL IMPLANTS FROM PATIENT AND PUT IN GAMMA 3 NAIL. A GAMMA 3 11 X 180 X 125 NAIL WAS USED TO COMPLETE THE SURGERY. THE ACTUAL CASE WAS DONE WITHIN 45-60 MINS. THIS WAS THE LAST STEP (REMOVING TARGETER) UPON COMPLETION AND THIS ADDED ABOUT AN HOUR TO PROCEDURE. THIS MEANT 60 MORE MINUTES OF OPEN SURGICAL WOUNDS, REDOING THE PROCEDURE USING GAMMA3, FURTHER BLOOD LOSS (OPEN WOUNDS), HIGHER RISK OF INFECTION (PROLONGED TIME OPEN WOUNDS, OPEN IMPLANTS), AND FURTHER TIME FOR A SICK PATIENT UNDER ANESTHETIC. PATIENT HAS SINCE BEEN RE INTUBATED FOR HYPOTENSION, RESPIRATORY FAILURE AND ISCHEMIC STROKE POST OP DAY 1. PATIENT ALSO HAS GONE ON TO HAVE FURTHER PERIOPERATIVE COMPLICATIONS INCLUDING RUPTURED ESOPHAGUS, NEEDING BILATERAL CHEST TUBES. HE REMAINS IN ICU IN CRITICAL CONDITION. THE PATIENT UNFORTUNATELY IS DECEASED (B)(6), MULTI SYSTEM ORGAN FAILURE. AUTOPSY DECLINED BY FAMILY ".

  Patient problems: Respiratory Insufficiency; Stroke/CVA

  MAUDE report 24686970 ↗
• 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 24560515 ↗
• MalfunctionFeb 12, 2026Failure to Align

  AS REPORTED: "DUE TO INSUFFICIENT ADJUSTMENT OF THE ADJUSTING DEVICE, THE MOST DISTAL ADVANCE LOCKING SCREW OF THE TWO DISTAL TRANSVERSE STOPS WAS INSERTED INTO THE BONE WITHOUT PASSING THROUGH THE NAIL. THIS WAS DISCOVERED AFTER WOUND CLOSURE. REINSERTION OF THE SCREW OUTSIDE THE NAIL WAS NOT PERFORMED, AND THE PLAN IS TO OBSERVE THE SITUATION AND TAKE ACTION AS APPROPRIATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328424 ↗
• MalfunctionFeb 6, 2026Failure to Align

  AS REPORTED: "DISTAL SCREW MISSED NAIL. EQUIPMENT DETERMINED TO BE DEFECTIVE BY SURGEON".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279683 ↗
• MalfunctionDec 18, 2025Device Difficult to Setup or Prepare; Failure to Align; Device Difficult to Setup or Prepare; Failure to Align

  IT WAS REPORTED THAT SINCE CONVERTING TO GAMMA4 INSTRUMENTS FROM GAMMA3, DR POTTER AND HIS GROUP HAVE OBSERVED THAT THE TREADS OF THE STRIKE PLATE APPEAR TO LOOSEN MORE THAN WHAT HAS BEEN OBSERVED TILT THE GAMMA 3 TARGETER/STRIKE PLATE. THEY HAVE OBSERVED THAT TARGETERS HAVE HAD DAMAGED THREADS BECAUSE THEY HAVE BEEN IMPACTED WHILST NOT FULLY SEATED. THE HYPOTHESIS IS THAT THE STRIKE PLATE IS LOOSENING DURING IMPACTION, AND THEN IMPACTED WHILE LOOSE THEREBY DAMAGING THE THREADS IN THE TARGETER. IN ADDITION TO THE STRIKE PLATE/TARGETER THREAD DAMAGE, DR POTTER HAS OBSERVED THAT THE NAIL HOLDING BOLT HAS ALSO BECOME LOOSE DURING NAIL INSERTION MORE THAN EXPERIENCED WITH GAMMA 3 INSTRUMENTATION REQUIRING RE-TIGHTENING OF THE NAIL HOLDING BOLT DURING INSERTION. THE LOOSENING OF THE NAIL HOLDING BOLT HAS CAUSED THE LAG SCREW/DISTAL LOCKING SCREW TO MISS THE NAIL BECAUSE OF LOOSING OF THE NAIL HOLDING BOLT. 15 MIN DELAY TO PERFORM MANUAL TARGETING/RE-TIGHTENING OF THE NAIL HOLDING BOLT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840358 ↗
• MalfunctionDec 2, 2025Failure to Align; Failure to Align

  THE FOLLOWING INFORMATION WAS REPORTED: "SEVERAL ADVANCED GAMMA SURGEONS HAVE SINCE THE INTRODUCTION OF GAMMA 4 EXPERIENCED ISSUES WITH THE DISTAL SCREW WHICH MISSES THE TROCH NAIL." THIS RECORD COVERS SURGERY 3 OUT OF 3.

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

  MAUDE report 23695000 ↗
• MalfunctionDec 2, 2025Failure to Align; Failure to Align

  THE FOLLOWING INFORMATION WAS REPORTED: "SEVERAL ADVANCED GAMMA SURGEONS HAVE SINCE THE INTRODUCTION OF GAMMA 4 EXPERIENCED ISSUES WITH THE DISTAL SCREW WHICH MISSES THE TROCH NAIL." THIS RECORD COVERS SURGERY 1 OUT OF 3.

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

  MAUDE report 23694999 ↗
• MalfunctionDec 2, 2025Failure to Align; Failure to Align

  THE FOLLOWING INFORMATION WAS REPORTED: "SEVERAL ADVANCED GAMMA SURGEONS HAVE SINCE THE INTRODUCTION OF GAMMA 4 EXPERIENCED ISSUES WITH THE DISTAL SCREW WHICH MISSES THE TROCH NAIL." THIS RECORD COVERS SURGERY 2 OUT OF 3.

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

  MAUDE report 23694997 ↗
• MalfunctionJun 18, 2025Failure to Align; Failure to Align

  AS REPORTED: " IN (B)(6) HOSPITAL WE WERE DOING A CASE AND THE K WIRE DIDN'T LINE UP WITH THE ROTATION OF THE JIG." THE SURGERY WAS COMPLETED SUCCESSFULLY BY OPENING A SECOND SET AND USING THE JIG. THERE WAS 30 MIN OF DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287870 ↗
• MalfunctionFeb 11, 2025Detachment of Device or Device Component; Mechanical Jam; Detachment of Device or Device Component; Mechanical Jam

  AS REPORTED: "THE GAMMA4 DEVICE AND THE NAIL ARE NO LONGER DISCONNECTED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354826 ↗
• MalfunctionNov 13, 2024Failure to Align; Failure to Align

  AS REPORTED: "WHEN THE SURGEON ATTEMPTED TO IMPLANT THE DISTAL LOCKING SCREW, THE SURGEON HIT THE NAIL WITH THE DRILL GOING THROUGH THE TRIPLE TROCARS ON GAMMA4 SYSTEM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20679676 ↗
• 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 20466720 ↗
• 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 20441027 ↗
• MalfunctionAug 21, 2024Failure to Align; Positioning Problem; Failure to Align; Positioning Problem

  IT WAS REPORTED THAT DURING A PRIMARY HIP FRACTURE SURGERY, THE SURGEON SUSPECTED THAT A DRILL MIGHT HAVE HIT A NAIL THROUGH THE TROCARS. IT WAS ALSO REPORTED THAT THE SURGEON INITIALLY THOUGHT SHE WAS IN THE DYNAMIC HOLE, BUT SWITCHED TO STATIC AND THE DRILL WORKED AS EXPECTED. THE NAIL WAS NOT EXPLANTED AND NO DAMAGE TO THE DRILL TIP WAS REPORTED, AND THE SAME SET WAS USED TO FINISH THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20009833 ↗
• MalfunctionAug 15, 2024Failure to Align; Failure to Align

  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 19997143 ↗
• MalfunctionJul 30, 2024Failure to Align; Failure to Align

  BOTH DISTAL LATERAL DRILLS WERE MISSED THROUGH THE DEVICE. SINCE ADJUSTMENT WITH THE DEVICE WAS NOT POSSIBLE, 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 19860124 ↗
• MalfunctionMay 8, 2024Failure to Align; Failure to Align

  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 19269520 ↗
• MalfunctionFeb 27, 2024Break; Crack; Fracture; Failure to Align; Break; Crack; Fracture; Failure to Align

  IT WAS REPORTED THAT DURING USE OF THE TARGETING ARM THE LAG SCREW REAMER MISSED THE NAIL AND BROKE. THE SURGEON WAS REALLY WRENCHING ON THE ARM TRYING TO GET THE REAMER TO PASS, WHICH MIGHT HAVE LED TO A CRACK IN THE TARGETER. ACCORDING TO ADDITIONAL INFORMATION RECEIVED THE "SURGEON OPENED 2ND REAMER THAT CONTINUED TO MISS THE NAIL - SOMETHING WAS OFF THE WITH THE TARGETING ARM. THE SURGEON HAMMERED THE REAMER IN, TO PROCEED WITH THE CASE. SURGEON WAS ABLE TO GET THE WIDER PART OF THE REAMER IN."

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

  MAUDE report 18793224 ↗
• MalfunctionJan 31, 2024Failure to Align; Failure to Align

  AS REPORTED: "G4 INTERMEDIATE NAIL MISS DRILL WAS OCCURRED ON LATERAL SIDE DURING DRILLING OF DISTAL DYNAMIC HOLE. PRE-CALIBRATION SHOWED CORRECT TARGETING. THE CORTICAL BONE AND NAIL WERE IN CONTACT AT THE LATERAL END, AND THE PHYSICIAN DETERMINED THAT THE MISS DRILL WAS DUE TO LOADING ON THE NAIL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18620128 ↗
• MalfunctionJan 3, 2024Failure to Align; Failure to Align

  AS REPORTED: "WHEN DRILLING TO INSERT A LATERAL STOP SCREW INTO THE DISTAL DYNAMIC HOLE, THE DRILL HIT INTO THE POSTERIOR WALL OF THE NAIL. SURGEON TRIED TO CORRECT THE TRAJECTORY, BUT BECAUSE OF THE HOLE, SURGEON ENDED UP NOT BEING ABLE TO INSERT THE SCREW THROUGH THE DEVICE, SO HE REMOVED THE DEVICE AND MANAGED TO INSERT THE SCREW FREEHAND."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18438072 ↗