GAMMA 3525-1360SRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07613252274285), received between Mar 7, 2019 and Sep 29, 2026 — classified as 14 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (11 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Fracture

  As reported: "The patient visited the doctor, and X-ray imaging confirmed a broken GAMMA3 Nail."

  Patient problems: Insufficient Information

  MAUDE report 50934328 ↗
• InjuryJun 30, 2026Fracture

  It was reported that, the surgery took place on (b)(6)2025. It was further reported, the fracture of a long Gamma3 nail in the area of the femoral neck screw, as well as fracture of a 5mm distal locking screw. No further information was provided.

  Patient problems: Insufficient Information

  MAUDE report 25667850 ↗
• InjuryMar 27, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "BROKEN GAMMA3 LONG NAIL. ON (B)(6) 2024 FIRST OPERATION. ON (B)(6) 2025 REVISION OPERATION".

  Patient problems: Fall; Insufficient Information; Pain

  MAUDE report 21713231 ↗
• InjuryJul 30, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "ON (B)(6) 2023, THE PATIENT, DUE TO THE FRACTURE OF HER LEFT FEMUR, UNDERWENT STABILIZATION SURGERY AT THE OSPEDALE DEGLI INFERMI DI BIELLA, DEPARTMENT OF ORTHOPEDICS - TRAUMATOLOGY, WHICH CONSISTED OF A NAIL INSTALLATION (LONG INTRAMEDULLARY NAIL STRYKER 360 MM ) AND CERCLAGE PROVIDED BY THE MENTIONED MEDICAL FACILITY. ON 20 FEBRUARY 2024, THE PATIENT, UPON LEAVING HOME, FOUND A STRONG BURNING SENSATION IN HER LEFT LEG, AS WELL AS PAIN WHEN WALKING AND AFTER GOING TO THE HOSPITAL IN BIELLA WHERE SHE SHOULD HAVE CARRIED OUT THE PRESCRIBED PHYSIOTHERAPY, SHE WAS TAKEN DIRECTLY TO THE EMERGENCY ROOM. AS A RESULT OF THE INVESTIGATIONS OF THE CASE, IN PARTICULAR THE RADIOGRAPHIC INVESTIGATIONS CARRIED OUT, THE BREAKAGE OF THE GAMMA LONG STRYKER ENDOMEDULLARY NAIL (PREVIOUSLY INSERTED BY THE DOCTORS OF THE BIELLA HOSPITAL) WAS FOUND IN THE FOLLOWING TERMS: FAILURE OF THE INTRAMEDULLARY NAIL AT IV OF THE CEPHALIC SCREW, AND THE PATIENT WAS INFORMED THAT IT WAS NECESSARY TO CARRY OUT A FURTHER OPERATION IN ORDER TO IMMEDIATELY REMOVE THE BROKEN NAIL. DUE TO THE CONTINUED HOSPITALIZATION, THE LACK OF ATTENTION TO THE PAIN REPEATEDLY COMPLAINED BY THE PATIENT AT THE INSERTION

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Implant Pain; Thrombosis/Thrombus

  MAUDE report 19859976 ↗
• MalfunctionDec 22, 2023Mechanical Jam; Mechanical Jam

  AS REPORTED: "DURING OSTEOSYNTHESIS SURGERY FOR SUBTROCHANTERIC FRACTURE OF THE FEMUR, A GAMMA 3 CEPHALOMEDULLARY NAIL IS USED, WHICH AT THE TIME OF INSERTING THE GRUB SCREW, IS WELDED TO THE INSIDE OF THE IMPLANT, PREVENTING THE PROPER BLOCKING OF THE SLIDING SCREW".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387610 ↗
• InjuryOct 9, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "BREAKAGE OF THE DM DETECTED BY X-RAY EXAMINATION. IT SHOULD BE NOTED THAT THE PATIENT IS UNDER PHARMACOLOGICAL TREATMENT FOR OSTEOPOROSIS. SIX MONTHS AFTER THE OPERATION, RETROTROCHANTERIC PAIN IN THE OPERATED LIMB IS REPORTED WITHOUT TRAUMA. FOLLOWING X-RAY, A RUPTURE OF THE DM WAS DETECTED. REVISION ON (B)(6) 2023 FOR NAIL REMOVAL AND PROSTHETIC IMPLANT PLUS PLATES AND CERCLAGES."

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 17901230 ↗
• InjurySep 29, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DUE TO A NAIL BREAKAGE A REVISION SURGERY WILL BE PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 17844160 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: IT WAS REPORTED THAT THE PATIENT'S RIGHT FEMUR WAS REVISED DUE TO NON-UNION. A GAMMA3 NAIL WAS REMOVED AND A SMALLER STEM IMPLANTED. NO STRYKER REP WAS PRESENT FOR THE REVISION. REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE."

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16728296 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A GAMMA NAIL PROCEDURE ON A FRACTURE DUE TO A TUMOR, THE CERVICAL SCREW DID NOT FIT INTO THE NAIL. THE NAIL HAD TO BE REMOVED AND CHANGED, WHICH RESULTED IN A REFRACTURE ON THE NEW NAIL. ADDITIONAL INFORMATION RECEIVED: THE EVENT OCCURRED DURING THE INSERTION OF THE CERVICAL SCREW. THE TUMOR CAUSED THE INITIAL FRACTURE THAT REQUIRED THE GAMMA NAIL. THE BONE BROKE WHEN THE FIRST NAIL WAS REMOVED, BECAUSE THE SCREW DID NOT FIT THROUGH THE FIRST NAIL. UPON REMOVAL OF THE 1ST NAIL, THERE WAS A RE-FRACTURE ADDITIONALLY, THERE WAS A SURGICAL DELAY OF UNKNOWN LENGTH REPORTED.

  Patient problems: Limb Fracture

  MAUDE report 16014664 ↗
• InjuryJul 25, 2022Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED THAT: "GAMMA NAIL INSTALLED ON (B)(6) 2022. THE NAIL BROKE! REMOVED ON (B)(6) 2022. ACTIONS TAKEN AT THE CARE FACILITY FOR PATIENT MANAGEMENT: DM REMOVED AND REPLACED WITH PLACEMENT OF DHS"

  Patient problems: Failure of Implant

  MAUDE report 15099971 ↗
• InjuryJun 28, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "PATIENT FELT CRACK IN LEFT HIP WHILE WALKING AND STRONG PAIN AFTER THAT. EVENT HAPPENED AFTER SURGERY, X RAY WAS MADE. REVISION SURGERY WILL BE MADE ON (B)(6) 2022."

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 14847988 ↗
• InjuryJun 23, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A GAMMA NAIL BROKE AND HAD TO BE EXPLANTED. REVISION SURGERY WAS PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 14786389 ↗
• InjuryDec 9, 2021Break; Break

  AS REPORTED: "ON (B)(6) 2021 THE HOSPITAL IMPLANT A NAIL 11X360, 125° 33250360TI, IT HAS TO BE CHANGED TODAY BECAUSE IT WAS BROKEN. THE PATIENT WAS REVISED ON (B)(6) 2021."

  Patient problems: Failure of Implant

  MAUDE report 12972103 ↗
• InjurySep 21, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A GAMMA NAIL BROKE AT THE LAG SCREW HOLE 4 MONTHS POST-OP. REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2021. MORE INFORMATION ABOUT THE REVISION HAS NOT BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 12509610 ↗
• InjuryJun 19, 2020Fracture; Fracture

  THE SURGEON HAS INFORMED THE SALES REP BY PHONE ABOUT A BROKEN GAMMA NAIL. ADDITIONALLY REPORTED: THE GAMMA NAIL BROKE AT THE THROUGH-HOLE FOR THE FEMORAL NECK SCREW.

  Patient problems: Injury

  MAUDE report 10176436 ↗
• MalfunctionOct 21, 2019Loose or Intermittent Connection; Failure to Advance; Physical Resistance/Sticking

  IT WAS REPORTED: "ONCE DOCTOR HAD LAG SCREW IN CORRECT POSITION ON THE FIRST NAIL, HE PUT IN THE SET SCREW BUT IT DID NOT ENGAGE INTO THE PROXIMAL PART OF NAIL. IT SPUN LOOSELY AND WOULD NOT ADVANCE FURTHER DISTALLY OR BACK OUT TO TRY AND RE-POSITION. THE SAME EXACT OUTCOME HAPPENED ON THE SECOND NAIL. THE SET SCREW ENTERED THE NAIL AND GOT STUCK. DOCTOR TRIED A COUPLE DIFFERENT SET SCREWDRIVERS TO TRY AND BACK IT OUT. BOTH NAILS RESULTED WITH STUCK SET SCREWS THAT DID NOT ENGAGE INTO THE LAG SCREWS. DELAY IN SURGERY: 20 MINUTES." PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DOCTOR CONCLUDED TO LEAVE BOTH OF THE NAILS IN. NO ADDITIONAL SURGERY IS PLANNED. NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9216243 ↗
• InjuryMar 7, 2019Break

  IT WAS REPORTED THAT THE PATIENT'S LEFT FEMUR WAS REVISED DUE TO A BROKEN GAMMA NAIL, POSSIBLE CAUSES OR CONTRIBUTORS FOR IMPLANT BREAKING, INCLUDING TRAUMA, WERE NOT REPORTED TO THE REP. THE ENTIRE NAIL CONSTRUCT WAS REVISED TO A HEMI HIP CONSTRUCT. AS REPORTED IN MEDWATCH REPORT # 30020-2019-002: "PATIENT WITH PREVIOUS LEFT INTERTROCHANTIC FEMUR FRACTURE, STATUS POST CEPHALOMEDULLY NAIL PLACEMENT ON (B)(6) 2018. IN JANUARY 2019 PATIENT EXPERIENCED PAIN AND X-RAYS SHOWED SHOWING FAILURE OF THE PROXIMAL ASPECT OF THE LEFT FEMUR CEPHALOMEDULLARY NAIL. THE NAIL HAD FAILED WHERE THE PROXIMAL INTERLOCKING SCREW FOR THE FEMORAL HEAD AND NECK, KNOCKING OFF THE PROXIMAL ASPECT OF THE NAIL. PATIENT UNDERWENT REMOVAL OF LEFT HIP FEMUR HARDWARE AND A LEFT HIP HEMIARTHROPLASTY USING RESTORATION MODULAR COMPONENTS". REPORT INDICATES THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: Pain

  MAUDE report 8401890 ↗