GAMMA 8225-0240SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327593723), received between Jan 3, 2024 and Sep 1, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2026Positioning Failure

  As reported: "On the (b)(6) 2026 a G4 Intermediate Nail has been used at (b)(6) Hospital. 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 50549684 ↗
• MalfunctionApr 22, 2026Positioning Failure

  AS REPORTED: "THE SET SCREW DRIVER WAS TURNED, BUT AS USUAL IT HAD SEIZED UP; HOWEVER, AS THE LAG SCREW TURNED, IT REMAINED IMMOVABLE WHETHER TURNED CLOCKWISE OR ANTI-CLOCKWISE. IT REMAINED IMMOVABLE EVEN AFTER SWITCHING TO A NEW TYPE OF SET SCREW; WHEN FORCED TO TURN IT, THE TIP OF THE NEW SET SCREW DRIVER BROKE, SO THE NAIL WAS REPLACED AND THE PROCEDURE WAS CONCLUDED." IT WAS CONFIRMED THAT THERE WAS NO DEBRIS LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24952575 ↗
• MalfunctionDec 21, 2025Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  AS REPORTED: "AN INTERMEDIATE NAIL FOR RIGHT WAS INSERTED ON THE LEFT SIDE INCORRECTLY. DURING THE LATERAL FIXATION DRILLING, THE LEFT-RIGHT REVERSAL WAS NOTICED. IT WAS SUGGESTED TO SWAP THE NAIL, HOWEVER, DUE TO CONCERNS ABOUT REDUCED FIXATION STRENGTH FROM SWAPPING THE LAG SCREWS, THE DOCTOR DECIDED NOT TO SWAP THEM. INSTEAD, LATERAL FIXATION SCREWS WERE INSERTED, AND THE PROCEDURE WAS COMPLETED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23861059 ↗
• MalfunctionDec 11, 2025Malposition of Device; Malposition of Device

  THE DISTRIBUTOR CONTACTED SR THE DAY AFTER THE OPERATION TO REPORT THAT THE SURGEON HAD COMPLETED THE PROCEDURE WHILST BOTH DISTAL SCREWS REMAINED OUT OF POSITION. FOLLOWING THE OPERATION, SR MET WITH THE DOCTOR, BUT AS THE SURGEON MADE NO MENTION OF THIS, IT CANNOT BE DEFINITIVELY CONFIRMED WHETHER THE SCREWS WERE INDEED OUT OF POSITION. ADDITIONAL INFORMATION: SR VISITED THE DOCTOR TO CONFIRM THIS MATTER. THE SURGEON STATED THAT HE HAD NOT NOTICED THE INCORRECT SCREW POSITION DURING THE OPERATION; IT WAS ONLY DISCOVERED ON THE POSTOPERATIVE X-RAY. THE SCREW WAS NOT REINSERTED. THIS WAS BECAUSE THE SCREW HOLE HAD BECOME RELATIVELY LARGE IN RELATION TO THE CORTICAL BONE, RAISING CONCERNS ABOUT A SECONDARY FRACTURE AT THAT SITE. GIVEN THE PATIENT'S WIDE MEDULLARY CAVITY, THIS WAS INTERPRETED AS A STATE OF HIGH NAIL OCCUPANCY, AND IT WAS DECIDED NOT TO IMPOSE ANY WEIGHT-BEARING RESTRICTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776339 ↗
• MalfunctionNov 17, 2025Positioning Problem; Positioning Problem

  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 23575460 ↗
• MalfunctionSep 19, 2025Malposition of Device; Malposition of Device

  AS REPORTED; "MISS TARGET OCCURRED DURING DRILLING FOR INSERTING THE SCREW TO THE DISTAL OVAL HOLE OF GAMMA4 NAIL. THE SCREW WAS ONCE REMOVED, FREEHAND DRILLING WAS PERFORMED, AND SCREW WAS REINSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY AFTER THAT WHILE THERE WAS ABOUT 10 MINUTES DELAY. THE SURGEON IS AWARE OF THE FACT THAT THERE IS NO PROBLEM WITH THE DEVICES BECAUSE A FUNCTIONAL CHECK OF THE NAIL AND THE TARGETING DEVICE WAS PERFORMED PRIOR TO INSERTION OF THE NAIL INTO THE PATIENT'S BODY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23097697 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "INITIAL SURGERY WAS PERFORMED FOR AN INTERTROCHANTERIC FRACTURE OF THE FEMUR. DURING NAIL INSERTION, A FRACTURE OCCURRED ON THE LATERAL SIDE OF THE FEMUR. A CABLE WAS ADDED TO COMPLETE THE PROCEDURE."

  Patient problems: Bone Fracture(s)

  MAUDE report 22962739 ↗
• InjuryJan 30, 2024Off-Label Use; Off-Label Use

  AS REPORTED: "SURGERY FOR FRACTURE OF LEFT FEMORAL CONDYLE. THE HOSPITAL OPERATING ROOM STAFF OPENED THE WRONG NAIL ON THE LEFT AND RIGHT SIDE AND INSERTED IT WITHOUT REALIZING THE MISTAKE. AFTER INSERTION, THE STAFF DID NOT NOTICE THE MISTAKE AND CONTINUED THE PROCEDURE. WHEN THEY ATTEMPTED TO INSERT THE LOCKING SCREW, IT DID NOT GO IN PROPERLY, RESULTING IN A FEMORAL DIAPHYSEAL FRACTURE. SUBSEQUENT CONFIRMATION REVEALED THAT THE WRONG NAIL HAD BEEN INSERTED ON THE LEFT AND RIGHT SIDE."

  Patient problems: Limb Fracture

  MAUDE report 18608377 ↗
• MalfunctionJan 3, 2024Device Damaged by Another Device; Device Damaged by Another Device

  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 18437850 ↗