GAMMA 3005-1105SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540374868), received between Mar 10, 2023 and Aug 9, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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, DELAYED UNION WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Impaired Healing

  MAUDE report 19956206 ↗
• InjuryMar 10, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "ON (B)(6) 2023, ACCORDING TO THE LETTER RECEIVED FROM THE MINISTRY, THE MOH RECEIVED THE ADVERSE EVENT REPORT PREPARED BY (B)(6) HOSPITAL. IN THE LETTER; IT IS STATED THAT THE PRODUCT WAS BROKEN AFTER IMPLANTATION. THE INCIDENT WAS REPORTED TO US BY THE MINISTRY OF HEALTH IN A LETTER DATED ON (B)(6) 2023. THE CASE WAS DATED ON (B)(6) 2022, BUT WE HAVE NO INFORMATION ABOUT WHEN THE IMPLANT BROKE." NEW INFORMATION RECEIVED 02 MAR 2023. THE PATIENT NAMED WAS OPERATED BY US ON (B)(6) 2022 FOR INTERTROCHANTERIC FEMUR FRACTURE AND THE NAIL NAMED ¿GAMMA3® NAIL¿ . ON (B)(6) 2022, THE PATIENT APPLIED TO US WITH PAIN IN THE HIP WITHOUT DESCRIBING ANY TRAUMA, AND THE X-RAYS SHOWED THAT THE NAIL ITSELF (NOT THE ¿END CAP¿) WAS BROKEN. THE PATIENT WAS RE-OPERATED FOR A REVISION SURGERY USING A DIFFERENT BRAND OF CEPHALOMEDULLARY NAIL. THE PATIENT WAS IN HIS 80S AND HIS BODY MASS INDEX WAS WITHIN NORMAL LIMITS. THE PATIENT¿S FIRST OPERATION WAS SUCCESSFUL WITHOUT ANY PROBLEM AND FULLY IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE OF THE RELATED NAIL. AS SEEN IN THE X-RAYS, BOTH THE FRACTURE REDUCTION AND THE NAIL PLACEMENT WERE PERFORMED IN ACCORDANCE WITH THE MEDICAL RULES. THE PATIE

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

  MAUDE report 16522456 ↗