GAMMA 3525-1400SRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613252274315), received between Nov 14, 2019 and Sep 14, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Fracture” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Fracture

  A broken Gamma3 nail as reported. The patient required revision surgery.

  Patient problems: Insufficient Information

  MAUDE report 50756193 ↗
• InjuryDec 15, 2025Fracture; Device Damaged by Another Device; Fracture; Device Damaged by Another Device

  IT WAS REPORTED THAT A GAMMA 3 LONG NAIL BROKE. THIS LEAD TO A REVISION SURGERY TO IMPLANT A PLATE.

  Patient problems: Insufficient Information

  MAUDE report 23805310 ↗
• InjuryJul 21, 2025Break; Fracture; Device Damaged by Another Device; Break; Fracture; Device Damaged by Another Device

  IT WAS REPORTED THAT A GAMMA3 NAIL, THAT WAS IMPLANTED 3 MONTHS AGO, FRACTURED AT THE LEVEL OF THE FEMORAL NECK SCREW RESULTING IN A REVISION SURGERY.

  Patient problems: Impaired Healing; Insufficient Information

  MAUDE report 22559881 ↗
• InjuryMay 22, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THE PATIENT WAS IMPLANTED WITH THE LONG GAMMA3 NAIL DESCRIBED ABOVE ON (B)(6) 2024 FOR A SUBTROCHANTERIC FRACTURE ON THE LEFT. HE WAS ABLE TO BE MOBILIZED UNDER FULL WEIGHT-BEARING DURING THE PROCEDURE. A FRACTURE OF THE LONG GAMMA NAIL WAS DIAGNOSED DURING A FOLLOW-UP X-RAY EXAMINATION, WHICH WAS PERFORMED DUE TO PAIN. ON (B)(6) 2025, REVISION SURGERY WAS PERFORMED WITH EXPLANTATION OF THE BROKEN GAMMA 3 NAIL ON THE LEFT."

  Patient problems: Pain

  MAUDE report 22072283 ↗
• InjuryAug 9, 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, PERSISTENT PAIN WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Implant Pain

  MAUDE report 19954796 ↗
• InjuryMar 26, 2024Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED: "I WOULD LIKE TO CONTACT YOU REGARDING THE ATTACHED REPORT ON A GAMMA NAIL. BREAKAGE OF THE NAIL AND DISTAL SCREW WHEN THE PATIENT MOVES (WALKING) NO NOTION OF TRAUMA. DEVICES INVOLVED: TWO. CLINICAL CONSEQUENCES OBSERVED: SECONDARY FRACTURE DISPLACEMENT FUNCTIONAL IMPOTENCE + PAIN PROTECTIVE MEASURES AND ACTIONS TAKEN: REMOVAL OF THE NAIL AND FITTING OF ANOTHER NAIL + GTR HOOK".

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Implant Pain; Limb Fracture

  MAUDE report 18981205 ↗
• InjuryJul 25, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A GAMMA 3 LONG NAIL BROKE. NAIL WILL BE EXPLANTED.

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

  MAUDE report 17393090 ↗
• InjuryAug 19, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT GAMMA NAIL AND SCREW BROKE. IMPLANTATION TOOK PLACE IN (B)(6) 2022. PATIENT STATED TO THE PHYSICIAN THAT HE HAD FOLLOWED THE PHYSICIAN'S INSTRUCTIONS, BUT HAD NOTICED PAIN WHILST WALKING. EXPLANTATION AND SIMULTANEOUS IMPLANTATION OF A NEW GAMMA3 NAIL.

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

  MAUDE report 15260081 ↗
• InjuryNov 6, 2021Fracture; Fracture

  THE CUSTOMER REPORTED THAT THE GAMMA NAIL WHICH WAS IMPLANTED IN (B)(6) 2021 HAS BROKEN POST IMPLANTATION, REQUIRING REVISION SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 12755552 ↗
• InjuryMay 27, 2021Fracture; Fracture

  THE CUSTOMER REPORTED: "79-YEAR-OLD FEMALE PATIENT OPERATED ON IN (B)(6) 2019 FOR A SUBTROCHANTERIC FRACTURE OF THE LEFT FEMUR REDUCED AND OSTEOSYNTHESIZED WITH GAMMA LONG NAIL. ON (B)(6) 2020, SHE CONSULTED THE EMERGENCY ROOM FOR PAIN IN THE LEFT THIGH THAT HAD BEEN EVOLVING FOR 1 WEEK. THE RADIOGRAPHIC WORKUP REVEALED FAILURE OF THE OSTEOSYNTHESIS MATERIAL OF THE LONG GAMMA NAIL REQUIRING A SURGICAL REVISION. ON THE RADIOGRAPHIC ASSESSMENT PERFORMED ON (B)(6) 2021 THE MATERIAL IS WELL IN PLACE AND NOT BROKEN. THERE IS A CLEAR IMPROVEMENT OF THE FOCUS OF PSEUDOARTHROSIS. INTERNALLY, WE HAVE THE IMPRESSION TO HAVE A GOOD BONE BASE AND IN PROFILE IT LOOKS AS IF ALL THE IMPRESSION THAT ALL THE CORTICES ARE SOLID. EXPLANTATION OF THE DEFECTIVE DM AND REIMPLANTATION OF A LONG GAMMA NAIL."

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 11898820 ↗
• InjuryMay 26, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE LEFT LONG GAMMA NAIL BROKE. IT WAS FURTHER REPORTED THAT AS A RESULT THE PATIENT HAD TO UNDERGO AN ADDITIONAL SURGERY TO HAVE A NEW FEMORAL NAIL INSERTED.

  Patient problems: Failure of Implant

  MAUDE report 11884886 ↗
• InjuryNov 13, 2020Fracture; Fracture

  THE CUSTOMER REPORTED THAT THE GAMMA NAIL HAD BROKEN WHERE THE NECK OF THE NAIL INTERFACES WITH THE LAG SCREW. THE NAIL WAS IMPLANTED A FEW MONTHS AGO. THE BROKEN NAIL AND IMPLANTS WERE REMOVED AND REVISED WITH 13MM GAMM.

  Patient problems: Failure of Implant

  MAUDE report 10840210 ↗
• InjuryNov 14, 2019Fracture; Fracture; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2019 ,BIKE ACCIDENT. ON (B)(6) 2019, GAMMA3 NAIL IMPLANTED. ON (B)(6) 2019, REVISION SURGERY. PATIENT VISITED HOSPITAL AFTER PAIN.

  Patient problems: Injury; Pain

  MAUDE report 9324326 ↗