NA 1896-5035SRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04546540202482), received between Aug 27, 2015 and Mar 24, 2026 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY SALES REP THAT THE PATIENT THAT WAS IMPLANTED IN 2012 NEED TO DO A REVISION SURGERY DUE TO THE INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 24676564 ↗
• InjuryMay 1, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "DISTAL SCREW BREAKAGE. THE SURGERY WAS PERFORMED FOR REASONS NOT DUE TO THE RUPTURE OF THE SCREW AND IT STILL HAD TO BE DONE. THE OPERATIVE TIME EXTENSION HAD NO CONSEQUENCES FOR THE PATIENT." ON 4/23/2024 - UPDATE THE CLINICIAN ALSO STATES THAT THE OPERATION OF (B)(6) 2024 WAS PERFORMED FOR REASONS NOT DUE TO THE BREAKAGE OF THE SCREW (REMOVAL OF TIBIAL NAIL) AND THAT THE BREAKAGE OF THE SCREW ONLY CAUSED AN EXTENSION OF THE SURGICAL TIMES (AS THE BROKEN SCREW CAUSED DIFFICULTIES IN REMOVAL).

  Patient problems: Failure of Implant

  MAUDE report 19226424 ↗
• InjuryNov 8, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "AFTER THE INITIAL SURGERY, THE FRACTURE BECAME PSEUDOARTICULAR AND THE NAIL EVENTUALLY BROKE OFF. AFTER REMOVAL, IT WAS REPLACED WITH THA."

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 18090438 ↗
• InjurySep 25, 2023Migration; Migration

  IT WAS REPORTED THAT THE DOCTOR PUT A NAIL IN TO HELP A BROKEN TIBIA AND 8-10 DAYS LATER PATIENT WENT IN AND HAD THE STAPLES TAKEN OUT AND WAS BANDAGED UP. A FEW HOURS (3-4) AFTER RETURNING HOME THE PATIENT NOTICED BLOOD AROUND THE BANDAGED AREA AND THE SCREW BACKING OUT. PATIENT CALLED THE DOCTOR AND WAS ADVISED TO GO THE ER. SCREW WAS REMOVED WHEN PATIENT WENT TO THE ER. SCREW PROTRUDING FROM LEFT SIDE ANKLE. ED RECOMMENDED WEARING A NON-WEIGHT BEARING BOOT. PT WAS PROVIDED A PRESCRIPTION FOR ANTIBIOTICS.

  Patient problems: Perforation

  MAUDE report 17807559 ↗
• InjuryMar 3, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "PAIN IN THE OPERATED AREA WITHOUT TRAUMA WITH SIGNIFICANT INCREASE IN THE COURSE. X-RAY DIAGNOSIS REVEALED SINTERING OF THE GAMMA NAIL WITH FRACTURE OF THE DISTAL LOCKING SCREW. PATIENT WAS OPERATED AGAIN."

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 16483201 ↗
• InjuryOct 7, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT GAMMA3 TROCHANTERIC NAIL BROKE. T2 FULLY THREADED LOCKING SCREW BROKE.

  Patient problems: Failure of Implant

  MAUDE report 15561964 ↗
• MalfunctionMar 12, 2021Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT UPON OPENING THE 5X35MM T2 LOCKING SCREW THE DEVICE INSIDE THE PACKAGING WAS MEASURED AT 33MM. THE CASE WAS COMPLETED WITH A DIFFERENT SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11476823 ↗
• MalfunctionSep 16, 2019Migration or Expulsion of Device

  IT WAS REPORTED THAT WHEN THE DRILL WAS INSERTED TO DISTAL SCREW HOLE OF GAMMA NAIL THROUGH THE TARGET DEVICE, THE DRILL WAS HIT TO THE SCREW HALL NAIL BUT THE SURGEON CONTINUED TO DRILL AND SCREW WAS IMPLANTED. AFTER THAT, THE SURGEON CONFIRMED THAT THE SCREW WAS BACKED OUT BUT THE SCREW WAS IMPLANTED BECAUSE IT WAS STUCK AND THE OPERATION WAS FINISHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9073105 ↗
• InjuryJun 18, 2019Break; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S LEFT FEMUR WAS REVISED DUE TO METAL FATIGUE CAUSING THE GAMMA NAIL TO BREAK AT THE JUNCTION WITH THE LAG SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8709676 ↗
• InjuryApr 4, 2019Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT GAMMA3 U-LAG SCREW SURGERY ON (B)(6) 2019. AFTER THE SURGERY, THE CUTOUT OF U-LAG SCREW AND THE BENDING OF U-BLADE WERE CONFIRMED. THEN GAMMA3 EXTRACTION AND REVISION TO THA WAS PERFORMED ON (B)(6) 2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8483029 ↗
• InjuryMay 29, 2018Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT PATIENT'S RIGHT TIBIA WAS REVISED AFTER PATIENT WALKED ON THE ROD AND DISPLACED IT. REP REPORTED THAT HE HAS NO ACCESS TO ANY ADDITIONAL INFORMATION DUE TO NOT BEING ALLOWED ACCESS TO THE HOSPITAL'S PASSWORD-PROTECTED SYSTEMS. REP REPORTED THAT THE NAIL AND 5 SCREWS (3 PROXIMAL, 2 DISTAL) WERE EXPLANTED. HOSPITAL IMPLANT SHEET SHOWS A NAIL AND 6 SCREWS. ADDITIONAL INFO RECEIVED FROM REP'S EMAIL: THERE WAS A SCREW EXCHANGE FROM THE PRIMARY SURGERY DUE TO LENGTH. ONLY 5 SCREWS WERE IMPLANTED. IN INITIAL SURGERY, A 6TH SCREW WAS USED BUT IMMEDIATELY TAKEN OUT. HE DOES NOT KNOW WHICH SCREWS WERE USED AND WHICH ONE WAS NOT USED. THE DISTAL TIBIA DISPLACED NOT THE TIBIAL ROD. ADDITIONAL INFO RECEIVED FROM PHONE CALL WITH REP: REVISION NEEDED BECAUSE "PATIENT WALKED ON LEG WHEN SHOULDN'T HAVE" AND THE BONE MOVED. SURGEON FELT THAT PLATES GAVE A BETTER REDUCTION SO HE SWITCHED FROM THE NAILING SYSTEM TO PLATING.

  Patient problems: No Information

  MAUDE report 7551264 ↗
• InjuryOct 1, 2015Insufficient Device Problem Information

  IT WAS REPORTED THAT IMPLANTS WERE EXPLANTED FROM PATIENT'S LEFT FEMUR DUE TO INFECTION AND NON-UNION. THE SURGEON DID NOT FEEL THE INFECTION WAS CAUSED BY THE IMPLANT HOWEVER DUE TO THE INFECTION IT WAS EXPLANTED.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 5116384 ↗
• InjuryOct 1, 2015Insufficient Device Problem Information

  IT WAS REPORTED THAT IMPLANTS WERE EXPLANTED FROM PATIENT'S LEFT FEMUR DUE TO INFECTION AND NON-UNION. THE SURGEON DID NOT FEEL THE INFECTION WAS CAUSED BY THE IMPLANT HOWEVER DUE TO THE INFECTION IT WAS EXPLANTED.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 5116380 ↗
• InjuryAug 27, 2015Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2014 A GAMMA 3 NAIL WAS IMPLANTED IN TO THE PATIENT AT THE (B)(6) HOSPITAL IN (B)(6). ANOTHER SURGERY WAS NEEDED ON (B)(6) 2015 INFACT AT THE TIME OF REMOVAL, IT SHOWED SECRETION (DURING SURGERY) THAT CAME FROM THE PERI-IMPLANT TISSUE. EXAMINATION OF GRANULOCYTES (WHITE BLOOD CELL COUNTS) POSITIVE IN EXTEMPORANEOUS.

  Patient problems: Fluid Discharge; Test Result

  MAUDE report 5036397 ↗