GAMMA 3003-0822SRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04546540374844), received between Jul 12, 2019 and Jan 7, 2026 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Positioning Failure

  AS REPORTED: "THE SET SCREWS FROM THE GAMMA NAIL KIT DID NOT HOLD IN THE NAIL. AFTERWARDS, A SEPARATELY PACKAGED SET SCREW WAS OPENED, BUT THIS ONE ALSO DID NOT HOLD IN THE NAIL. SUBSEQUENTLY, A NEW NAIL WAS IMPLANTED, AND THE SET SCREW THAT CAME WITH THIS NAIL WORKED AS INTENDED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23991424 ↗
• MalfunctionApr 24, 2024Malposition of Device; Malposition of Device

  AS REPORTED: "GAMMA 3 SET SCREW DID NOT ENGAGE WITH THE GAMMA 3 LAG SCREW. THE FLEXIBLE SET SCREWDRIVER WAS USED TO TRY AND REMOVE THE SET SCREW, BUT THE DRIVER BECAME DAMAGED. THE SURGEON MADE THE DECISION TO LEAVE THE GAMMA NAIL IN THE PATIENT WITH THE SET SCREW NOT ENGAGED WITH THE GAMMA LAG SCREW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19176667 ↗
• MalfunctionFeb 1, 2024Malposition of Device; Malposition of Device

  AS REPORTED: "THE GAMMA 3 SET SCREW WAS NOT INSERTED PROPERLY AND THE OPERATION WAS COMPLETED. POSTOPERATIVE X-RAYS SHOWED THAT THE SET SCREW REMAINED INSIDE THE BODY."

  Patient problems: Foreign Body In Patient

  MAUDE report 18623703 ↗
• MalfunctionJan 23, 2024Off-Label Use; Off-Label Use

  AS REPORTED: "AFTER COMPLETION OF AN ORIF IMPLANTING GAMMA3 IN RIGHT FEMUR FOR PROXIMAL FEMORAL FRACTURE ON (B)(6) 2023, THE DOCTOR REALIZED HE FORGOT TO USE THE SET SCREW IN THE SURGERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563723 ↗
• InjuryOct 27, 2023Device Difficult to Setup or Prepare; Noise, Audible; Device Difficult to Setup or Prepare; Noise, Audible

  AS REPORTED: "THE SET SCREW GOT STUCK IN THE MIDDLE OF THE NAIL AND THE SCREWDRIVER FOR THE SET WAS NOT TURNING HALFWAY. WHEN TIGHTENED HARD, IT MADE A CREAKING SOUND AND THE SITUATION WAS COMPLETELY DIFFERENT FROM USUAL. WE TRIED A NEW SET SCREW, BUT THE RESULT WAS THE SAME. WE THOUGHT THAT THE NAIL WAS NOT GOOD, REMOVED IT, OPEN A NEW DIFFERENCE NAIL, AND PERFORM THE OPERATION. THE OPERATION TOOK TWICE AS LONG AS USUAL, PUTTING A BURDEN ON THE PATIENT, BUT IT WAS COMPLETED SUCCESSFULLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18020950 ↗
• InjuryOct 27, 2023Device Difficult to Setup or Prepare; Noise, Audible; Device Difficult to Setup or Prepare; Noise, Audible

  AS REPORTED: "THE SET SCREW GOT STUCK IN THE MIDDLE OF THE NAIL AND THE SCREWDRIVER FOR THE SET WAS NOT TURNING HALFWAY. WHEN TIGHTENED HARD, IT MADE A CREAKING SOUND AND THE SITUATION WAS COMPLETELY DIFFERENT FROM USUAL. WE TRIED A NEW SET SCREW, BUT THE RESULT WAS THE SAME. WE THOUGHT THAT THE NAIL WAS NOT GOOD, REMOVED IT, OPEN A NEW DIFFERENCE NAIL, AND PERFORM THE OPERATION. THE OPERATION TOOK TWICE AS LONG AS USUAL, PUTTING A BURDEN ON THE PATIENT, BUT IT WAS COMPLETED SUCCESSFULLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18020947 ↗
• MalfunctionFeb 24, 2022Mechanical Jam; Mechanical Jam

  AS REPORTED: "THE SET SCREW GOT STUCK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13596087 ↗
• MalfunctionFeb 22, 2022Positioning Failure; Positioning Failure

  AS REPORTED: "SURGEON IS PERFORMING A GAMMA OPERATION. WHEN HE IS TO PLACE THE SET SCREW HE IS NOT ABLE TO GET THE SET SCREW TO CONNECT WITH THE LAG SCREW. THE SET SCREW IS LOCKED IN THE NAIL BEFORE IT CONNECTS WITH THE LAG SCREW. THEY TRY WITH ANOTHER SET SCREW AND GETS THE SAME RESULT. THEY THEN REMOVE THE NAIL AND TRY OUTSIDE THE PATIENT. AGAIN THE SAME RESULT. BOTH SET SCREWS ARE TIGHTENED IN THE NAIL BEFORE REACHING THE LAG SCREW. THEY THEN TOOK A NEW NAIL WITH ANOTHER LOT NO. AND WERE THEN ABLE TO PERFORM THE OPERATION. THE PATIENT WAS UNNECESSARILY UNDER ANESTHESIA FOR AN HOUR WHERE THE SURGEON AND NURSES TRIED TO FIND A SOLUTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13577398 ↗
• MalfunctionNov 24, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED: "WHILE INSERTING THE GAMMA3 SET SCREW THE SCREW WOULD NOT ENGAGE INTO THE NAIL. FOLLOWING MULTIPLE ATTEMPTS THE NAIL WAS REMOVED AND REPLACE AND THE SET SCREW ENGAGE INTO THE NEW NAIL" A SURGICAL DELAY WAS REPORTED; HOWEVER THE LENGTH OF THE SURGICAL DELAY WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12867649 ↗
• MalfunctionNov 24, 2021Difficult to Insert; Device Difficult to Setup or Prepare; Difficult to Insert; Device Difficult to Setup or Prepare

  AS REPORTED: "WHILE INSERTING THE GAMMA3 SET SCREW THE SCREW WOULD NOT ENGAGE INTO THE NAIL. FOLLOWING MULTIPLE ATTEMPTS THE NAIL WAS REMOVED AND REPLACE AND THE SET SCREW ENGAGE INTO THE NEW NAIL." A SURGICAL DELAY WAS REPORTED; HOWEVER THE LENGTH OF THE SURGICAL DELAY WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12867647 ↗
• MalfunctionSep 23, 2021Migration; Migration

  IT WAS REPORTED A GAMMA 3 SET SCREW STRAYED INTO THE BODY DUE TO BEING BURIED OUTSIDE THE NAIL AND WAS DIFFICULT TO REMOVE, SO THE OPERATION WAS COMPLETED WITH THE SCREW STILL IN THE BODY. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12522776 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "MY PHYSICIAN DISCOVERED WITH X RAYS THAT YOUR HARDWARE FAILED THAT WAS SURGICAL IMPLANTED IN MY RIGHT LEG ON (B)(6) 2019. ON (B)(6) 2020, A TRAUMA SURGEON REMOVED THE DEFECTIVE HARDWARE FROM MY LEG AT (B)(6) HOSPITAL IN (B)(6). AS A RESULT, SHE HAS MISSED 8 MONTHS FROM WORK, AND SHE WILL PROBABLY MISS 2 MORE MONTHS FOR PHYSICAL THERAPY.

  Patient problems: Failure of Implant

  MAUDE report 10924800 ↗
• InjuryJul 12, 2019Material Deformation; Material Deformation

  THE LOCKING BOLT COULD NOT BE FINALLY TIGHTENED. FIRST THE MEDICAL PROCEDURE WAS COMPLETED SUCCESSFULLY BUT IT WAS NOTICED BY X-RAY THAT A REVISION HAS TO BE DONE AND THE NAIL HAS TO BE REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8784459 ↗