GAMMA 8325-0240SRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327593877), received between Jan 31, 2024 and Jul 28, 2026 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Fracture

  As reported: "Primary surgery was performed on (b)(6)2026. The nail broke off at the lag screw hole during postoperative follow-up.Revision surgery was performed on (b)(6)-2026, and Gamma4 was removed and DC nail of Hansson was implanted."

  Patient problems: Insufficient Information

  MAUDE report 50061358 ↗
• MalfunctionJul 20, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25881382 ↗
• InjuryJul 6, 2026Unstable

  It was reported that, postoperatively, the distal screw came loose. A revision surgery was performed to replace the nail with a long nail. No further information was provided.

  Patient problems: Insufficient Information

  MAUDE report 25724687 ↗
• MalfunctionApr 30, 2026Positioning Failure

  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 25046345 ↗
• MalfunctionApr 20, 2026Malposition of Device

  AS REPORTED: "AFTER INSERTING THE GAMMA4 INTERMEDIATE NAIL AND DRILLING FOR THE DISTAL LOCKING SCREW, THE DRILL BIT AND THE NAIL INTERFERED WITH EACH OTHER, AND AS A RESULT, WE WERE UNABLE TO INSERT ONE OF THE TWO LOCKING SCREWS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932110 ↗
• InjuryMar 19, 2026Fracture

  AS REPORTED: "THE PATIENT UNDERWENT A REVISION SURGERY DUE TO THE NAIL BREAKING AT THE LAG SCREW JUNCTION".

  Patient problems: Insufficient Information

  MAUDE report 24640810 ↗
• MalfunctionMar 10, 2026Positioning Failure

  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 24560302 ↗
• MalfunctionDec 17, 2025Positioning Failure; Positioning Failure

  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 23834447 ↗
• InjuryDec 3, 2025Fracture; Device Damaged by Another Device; Fracture; Device Damaged by Another Device

  AS REPORTED: "LEFT INTERMEDIATE GAMMA NAIL BROKE AT THE STATIC SCREW HOLE".

  Patient problems: Insufficient Information

  MAUDE report 23707111 ↗
• MalfunctionOct 18, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED AFTER THE FIRST USE OF GAMMA 4 WITHOUT THE PRESENCE OF THE SALES REP, THE DOCTOR NOTICED THAT HE FORGOT TO TIGHTEN THE SET SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20483716 ↗
• MalfunctionJan 31, 2024Device Damaged by Another Device; Device Damaged by Another Device

  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 18620127 ↗