GAMMA 3525-1380SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613252274292), received between Sep 7, 2018 and Apr 17, 2025 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Mechanical Jam; Mechanical Jam

  THE CUSTOMER REPORTED THAT : "OPERATION ON LEFT FEMUR. WHEN THE GAMMA NAIL WAS INSERTED, IT BECAME STUCK ON THE GUIDE. CONSEQUENCE OPENING OF A NEW NAIL TO CONTINUE THE OPERATION.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21854653 ↗
• 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 19954047 ↗
• InjuryApr 30, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED: "PATIENT HAD AN ACCIDENT ON (B)(6) 2023 HE UNDERWENT SURGERY AND AFTER A FEW MONTHS OF SURGERY AND ALREADY UNDERGOING PHYSIOTHERAPY, ON 02/19/24 HE WOKE UP WITH SEVERE PAIN IN THE HIP, UNABLE TO SUPPORT THE LEG ON THE FLOOR. ON THAT DAY, HE STARTED USING BRACES AGAIN AND WENT TO THE DOCTOR AND 'WHEN CARRYING OUT TESTS THEY FOUND THAT THE GAMMA3 IMPLANT HAD BROKEN. ON (B)(6) 2024, HE UNDERWENT ANOTHER PROCEDURE TO REMOVE THE BROKEN IMPLANT AND PLACED ANOTHER GAMMA3.

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

  MAUDE report 19216015 ↗
• InjuryNov 8, 2022Break; Fracture; Adverse Event Without Identified Device or Use Problem; Break; Fracture; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED PAIN AND LAMENESS WHEN WALKING, WHICH REQUIRED REVISION SURGERY.

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

  MAUDE report 15756090 ↗
• InjuryOct 11, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT GAMMA NAIL BROKE 3 MONTHS AFTER INSERTION. GAMMA NAIL WAS EXTRACTED AND NEW NAIL WAS INSERTED.

  Patient problems: Failure of Implant

  MAUDE report 15584779 ↗
• InjuryJan 20, 2022Break; Fracture; Break; Fracture

  CUSTOMER REPORTED A BROKEN GAMMA NAIL 3 TITANIUM. ON THE (B)(6) 2021 THE BROKEN GAMMA NAIL WAS REMOVED AND A PSEUDARTHROSIS TREATMENT WAS PERFORMED (TISSUE SAMPLING, CLEANING OF FRACTURE SITE, RE-OSTEOSYNTHESIS WITH A PROXIMAL FEMORAL PLATE ON THE LATERAL SIDE AND AN AO SMALL FRAGMENT PLATE ON THE VENTRAL SIDE WITH SPONGIOSA/FILLING WITH BONE- CHIPS). A BROKEN SCREW WAS ALSO REPORTED.

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

  MAUDE report 13303790 ↗
• InjuryApr 23, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S FEMUR WAS REVISED DUE TO A BROKEN GAMMA NAIL. THE NAIL WAS REMOVED AND ANOTHER PUT IN ITS PLACE. REP REPORTED THAT NO FURTHER PATIENT-SPECIFIC INFORMATION IS AVAILABLE. ADDITIONALLY, THE REP REPORTED: THE NAIL BROKE AT THE JUNCTION OF THE LAG SCREW, AND THERE WAS NON-UNION OF THE PATIENT'S BONE. THE NAIL, LAG SCREW, AND TWO DISTAL SCREWS WERE REVISED TO ANOTHER GAMMA NAIL. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 9990313 ↗
• InjuryOct 4, 2019Break; Fracture; Fracture

  BROKEN GAMMA NAIL. PATIENT HAD PAIN AND WENT TO THE HOSPITAL. REVISION OPERATION: (B)(6) 2019 - LONG GAMMA NAIL USED.

  Patient problems: Failure of Implant; Injury; Pain

  MAUDE report 9158520 ↗
• InjuryFeb 19, 2019Break; Fracture; Fracture

  CUSTOMER REPORTED THAT THE GAMMA NAIL HAS BROKEN AT LAG SCREW INTERFACE. PATIENT UNDERWENT REVISION SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8351623 ↗
• InjurySep 7, 2018Break

  SURGEON HAS SUGGESTED A GAMMA NAIL HAS BROKEN EARLY WITHOUT ANY TRAUMA ASSOCIATED WITH THE BREAK. IT WAS IMPLANTED IN (B)(6) 2018, AND THE SURGEON REPLACED IT TODAY NOTING THAT THERE WAS NO TRAUMA ASSOCIATED TO CAUSE A BREAK. A REPLACEMENT NAIL WAS INSERTED. THE SURGEON ASKED THE REP IN ATTENDANCE TO REPORT IT IN CASE THERE WAS AN ISSUE WITH NAILS BREAKING EARLY.

  Patient problems: No Code Available

  MAUDE report 7856940 ↗