GAMMA 3425-1380SRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07613252273844), received between Mar 18, 2019 and Jun 16, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Fracture” (13 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2026Fracture

  AS REPORTED: "A (B)(6) PATIENT, INITIALLY TREATED ON (B)(6) 2026. NO IMPLANTATION ERRORS DETECTED; NAIL FRACTURE AT A BODY WEIGHT OF APPROXIMATELY 70 KG AS EARLY AS (B)(6), I.E. BARELY 8 WEEKS POST-OPERATION. REVISION SURGERY WITH A PROSTHESIS".

  Patient problems: Insufficient Information

  MAUDE report 25521165 ↗
• InjuryApr 1, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "BROKEN GAMMA 3 NAIL, IMPLANTED (B)(6) 2024, REMOVED TODAY. PRIMARY SURGERY (B)(6) 2024 ANNA-KAJSA HARDING, NO PROBLEMS DURING SURGERY LAB TESTS, NOTHING DEVIANT HYPERTONI, ARTRIAL FIBRILLATION FELL TWICE BEFORE SHE SOUGHT MEDICAL ATTENTION AGAIN."

  Patient problems: Fall

  MAUDE report 21739997 ↗
• InjurySep 5, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE IMPLANTATION TOOK PLACE ON (B)(6) 2023 WITHOUT PROBLEMS. IN (B)(6) 2023, A NAIL FRACTURE OCCURRED DURING REHAB.

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

  MAUDE report 20153763 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, DELAYED UNION WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Impaired Healing

  MAUDE report 19938446 ↗
• InjuryJul 30, 2024Break; Fracture; Device Damaged by Another Device; Break; Fracture; Device Damaged by Another Device

  AS REPORTED: ''BROKEN GAMMA3 LONG NAIL. REVISION WAS ON (B)(6) 2024'."

  Patient problems: Failure of Implant

  MAUDE report 19860935 ↗
• InjuryFeb 27, 2024Break; Fracture; Device Damaged by Another Device; Break; Fracture; Device Damaged by Another Device

  AS REPORTED: THE PATIENT'S ATTORNEY CONTACTED STRYKER WITH THE FOLLOWING ISSUE: THE PATIENT WAS OPERATED ON AT THE BEGINNING OF (B)(6) 2023 FOR A FRACTURE OF THE FEMORAL NECK AND A GAMMA NAIL WAS INSERTED. ON (B)(6) 2023, THE GAMMA NAIL BROKE IN THE AREA OF THE RIGHT THIGH. THE PATIENT SUBSEQUENTLY HAD AN INPATIENT STAY FROM (B)(6) 2023 TO (B)(6) 2023.

  Patient problems: Failure of Implant

  MAUDE report 18788837 ↗
• InjuryJan 9, 2024Break; Fracture; Break; Fracture

  AS REPORTED BY THE HOSPITAL RISK MANAGER: "THE PATIENT REPORTS HAVING BEEN OPERATED ON (B)(6) 2023, IN AT ANOTHER HOSPITAL, FOR A FRACTURE OF THE PROXIMAL FEMUR WITH A GAMMA 3 LONG NAIL. IN (B)(6) 2023, THE PATIENT WENT TO ANOTHER EMERGENCY ROOM AND FOUND THAT THE FEMORAL FIXATION DEVICE HAD BROKEN. THEY WENT TO OUR HOSPITAL FOR THE SURGICAL REMOVAL AND NEW OSTEOSYNTHESIS OF THE LEFT FEMUR."

  Patient problems: Failure of Implant

  MAUDE report 18473738 ↗
• InjuryOct 25, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PATIENT HAD A LONG GAMMA NAIL IN HER RIGHT FEMUR, WHICH BROKE SPONTANEOUSLY DURING REHABILITATION, NECESSITATING A RETURN TO THE OPERATING THEATRE. ACTIONS TAKEN IN THE CARE FACILITY TO MANAGE THE PATIENT: RETURN TO THE OPERATING ROOM TO REMOVE THE MATERIAL, THEN FITTING OF A NEW OSTEOSYNTHESIS.

  Patient problems: Failure of Implant

  MAUDE report 18001962 ↗
• InjuryJan 3, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THERE WAS A BROKEN GAMMA NAIL 6 MONTHS AFTER IMPLANTATION. THE PATIENT WAS REVISED TO A RECON NAIL.

  Patient problems: Failure of Implant

  MAUDE report 16086446 ↗
• InjuryNov 24, 2021Break; Break

  AS REPORTED: "THE PATIENT CAME IN WITH PAIN. FRACTURE OF GAMMA -NAIL LONG AT FEMORAL NECK SCREW, NO NEW FALL. THE PATIENT REQUIRED A REVISION SURGERY."

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 12867646 ↗
• InjurySep 24, 2021Fracture; Fracture

  THE CUSTOMER REPORTED THERE WAS A SPONTANEOUS FRACTURE OF THE IMPLANTABLE MEDICAL DEVICE. REVISION SURGERY WAS REQUIRED TO PUT THE NAIL BACK IN PLACE.

  Patient problems: Failure of Implant

  MAUDE report 12530129 ↗
• InjuryDec 12, 2020Fracture; Fracture

  THE CUSTOMER REPORTED THAT THE GAMMA 3 FEMORAL NAIL (RIGHT) BROKE AT PROXIMAL END IN-SITU, JUST ABOVE LAG SCREW HOLE. THE NAIL HAS SUBSEQUENTLY SUNK AND CAUSED THE DISTAL LOCKING SCREWS TO SNAP. THIS NAIL HAS BEEN SUCCESSFULLY EXTRACTED AND REVISED.

  Patient problems: Failure of Implant; Fall; Implant Pain

  MAUDE report 10996126 ↗
• InjurySep 2, 2020Fracture; Fracture

  AS REPORTED: "ON (B)(6) 2020, A PROPHYLACTIC NAILING WAS REALIZED IN CASE OF IMMINENT FRACTURE. A NAIL FRACTURE WAS CONFIRMED AFTER METAL REMOVAL ON (B)(6) 2020."

  Patient problems: Failure of Implant; Injury

  MAUDE report 10484701 ↗
• InjuryJun 7, 2019Fracture; Material Deformation; Break; Fracture; Material Deformation

  THE CUSTOMER REPORTED THAT A BROKEN GAMM NAIL IS BEING REMOVED. THIS WAS IMPLANTED DURING JANUARY 2019 AND THE SURGEON REPORTED THAT IT HAS BROKEN AROUND THE LAG SCREW. THE PATIENT WAS WALKING A GOT A SUDDEN SHARP PAIN AND WAS UNABLE TO WALK.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 8680476 ↗
• InjuryMar 18, 2019Break; Fracture; Fracture

  A NAIL WAS PLACED IN A PATIENT AT (B)(6) 2018. THE ELONGATED NAIL WAS PLACED IN A (B)(6) YEAR OLD FEMALE PATIENT. SINCE THE FIRST WEEK OF JANUARY SHE DEVELOPED SEVERE PAIN IN HER RIGHT HIP. ON (B)(6) 2019, IT SEEMED VIA X-RAY THAT THE NAIL HAS BEEN BROKEN. ON (B)(6) 2019, SURGEON PERFORMED EXPLANT OF BROKEN NAIL AND NEW NAIL WAS IMPLANTED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8430074 ↗