GAMMA 1420-0110Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327479911), received between Feb 14, 2024 and Sep 28, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Failure to Align

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917223 ↗
• MalfunctionApr 20, 2026Positioning Failure

  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 24927423 ↗
• MalfunctionFeb 6, 2026Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279486 ↗
• MalfunctionJun 18, 2025Failure to Align; Failure to Align

  AS REPORTED: " IN (B)(6) HOSPITAL (B)(6) 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 22287868 ↗
• MalfunctionJun 13, 2025Failure to Align; Failure to Align

  AS REPORTED: "I WAS COVERING A SHORT GAMMA CASE AT (B)(6) HOSPITAL AND THE DISTAL TARGETER DIDN'T WORK, THE SURGEON COULD NOT PASS THE DRILL THROUGH THE DISTAL HOLE." "DISTAL LOCKING ON SHORT NAIL NOT FUNCTIONING. THE DRILL WAS TOUCHING THE NAIL, RATHER THAN GOING THROUGH IT. FREE HAND TECHNIQUE WAS USED TO FINISH THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205179 ↗
• MalfunctionApr 17, 2025Device Difficult to Setup or Prepare; Failure to Align; Device Difficult to Setup or Prepare; Failure to Align

  IT WAS REPORTED THAT: "DURING AN OPERATION ON (B)(6) 2025, THE SURGEON ENCOUNTERED A FEW DIFFICULTIES WHEN FITTING THE NAIL REF. (B)(4). APPARENTLY, THE CEPHALIC SCREW DID NOT FIT INTO THE NAIL." "MINI-ABUTMENT OF A VERY COMPLEX EPIPHYSEAL-DIAPHYSEAL FRACTURE. COMPLEX EPIPHYSEAL-DIAPHYSEAL FRACTURE. OPENING OF THE FASCIA LATA. DRILLING OF THE GREATER TROCHANTER. PLACEMENT OF REAMING GUIDE NAIL. REAMING TO DIAMETER 13 DIAPHYSEAL AND 14 METAPHYSEAL. PLACEMENT OF A NAIL DIAMETER 10, 125° CERVICAL ANGULATION, 240 LENGTH. PLACEMENT OF THE CERVICAL GUIDE PIN, WHICH WILL BE CHECKED FROM FRONT AND SIDE. CERVICAL REAMING. MEASURE LENGTH BACK TO 110. PLACE CERVICAL SCREW LENGTH 110 WHICH WILL BE LOCKED. PLACE DISTAL SCREW LENGTH TO 37.5. SCOPIC CHECK: TECHNICAL INCIDENCE, GIVEN THE ECCENTRICITY OF THE CERVICAL SCREW TO THE NAIL. ATTEMPT TO REDUCE THE OSTEOSYNTHESIS USING THE SAME MATERIAL WAS UNSUCCESSFUL. PATIENT'S CURRENT CONDITION: LONGER OPERATING TIME (60 MIN). ACTIONS TAKEN IN HOSPITAL TO MANAGE PATIENT: CHANGE OF EQUIPMENT AND CERCLAGE OF FRACTURE SITE. NAIL LENGTH 260, DIAMETER 10, ANGULATION 125°. PLACEMENT OF GUIDE WIRE, CHECKED FROM FRONT AND SIDE. BORE LENGTH 110. LOCKED 110 SCRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857136 ↗
• MalfunctionMar 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE TARGETING SLEEVE MOVEMENT OF THE GAMMA 4 WAS FAULTY. THE TARGETING SLEEVE HAD COME LOOSE FROM THE TARGET DEVICE DURING OPERATION DUE TO THE METAL PIN ATTACHED TO THE SLEEVE COMING LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21566054 ↗
• MalfunctionAug 20, 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 20002372 ↗
• 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 19900736 ↗
• MalfunctionFeb 14, 2024Device Difficult to Setup or Prepare; Failure to Align; Device Difficult to Setup or Prepare; Failure to Align

  IT WAS REPORTED THAT THE SLEEVE FOR GAMMA4 WAS NOT WORKING CORRECTLY, IT WOULDN'T LOCK IN. 24-JAN-2024-UPDATE. INTRA-OP-SLEEVE WAS NOT LOCKING TO TARGETING GUIDE. TRIPLE SLEEVE TYPICALLY LINES INTO THE DRILL HOLE FOR THE NAIL BUT BECAUSE THE GUIDE WAS NOT ENGAGE IT WAS GOING POSTERIOR TO THE NAIL, AND THE NAIL WAS MISSED. HAD TO TAKE OFF THE GUIDES AND DO PERFECT CIRCLES AND COMPLETE THE SURGERY FREE HAND. LONGER OR TIME 20-25 MINS. METAL CIRCULAR PIECE NEEDED TO BE MALLETED DOWN TO FUNCTION AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18707517 ↗