GAMMA 3525-0260SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540375698), received between Sep 6, 2018 and Dec 22, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "DURING INSERTION OF 260MM GAMMA3 LONG NAIL, THE BONE HAD A HAIRLINE FRACTURE. THE 260MM NAIL WAS REMOVED AND THE 320MM NAIL WAS INSERTED INSTEAD TO COMPLETE THE PROCEDURE."

  Patient problems: Limb Fracture

  MAUDE report 23869626 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "OVER-TELESCOPING OF THE LAG SCREW DUE TO NON-UNION. THE SCREW DOES NOT HAVE A CUTOUT. THE LAG SCREW PROTRUDED TO LATERAL DUE TO COLLAPSE OF THE FEMORAL NECK. THE PATIENT REQUIRED A REVISION SURGERY."

  Patient problems: Perforation

  MAUDE report 23318037 ↗
• InjuryMay 7, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A NONUNION OCCURRED AND THE NAIL BROKE OFF AT THE LAG SCREW HOLE. IT WAS A SPECIAL CASE WITH REDUCTION DIFFICULTY.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 14323697 ↗
• InjuryJan 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "ON (B)(6) 2020 THE INITIAL SURGERY UNDER THE TROCHANTER OF THE FEMUR (LEFT) WAS PERFORMED. ON (B)(6) 2021 RE-OPERATION WAS PERFORMED. THE REMAINING GAP IN THE FRACTURE WOULD HAVE PUT A LOAD ON THE NAIL, CAUSING NONUNION AND NAIL BREAKAGE."

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11223039 ↗
• InjuryMay 20, 2020Fracture; Fracture

  IT WAS REPORTED, SUBTROCHANTERIC FRACTURE OF THE FEMUR ON (B)(6) 2019. THE LONG GAMMA NAIL WAS USED. ON (B)(6) 2020, THE NAIL WAS BROKEN STARTING FROM THE NAIL LAG SCREW INSERTION HOLE. THA SCHEDULED FOR REVISION.

  Patient problems: Injury

  MAUDE report 10076710 ↗
• InjuryMar 27, 2020Fracture; Fracture

  IT WAS REPORTED, ON (B)(6) 2019 THE PATIENT UNDERWENT OPERATION WITH GAMMA 3 NAIL. A FEW MONTHS AFTER THE SURGERY, THE PATIENT¿S PAIN CONTINUED. ON (B)(6) 2020 AT THE TIME OF THE HOSPITAL VISIT, BREAKAGE OF THE GAMMA NAIL WAS CONFIRMED. THE REVISION BHA PROCEDURE WAS PERFORMED WITH OTHER COMPANY PRODUCT.

  Patient problems: Injury; Pain

  MAUDE report 9890722 ↗
• InjurySep 6, 2018Break

  THE PATIENT UNDERWENT A PRIMARY SURGERY WITH GAMMA NAIL ON (B)(6) 2017. ON (B)(6) 2018, IT WAS FOUND THAT THE NAIL WAS BROKEN AT THE TIME OF VISIT FOR FOLLOW-UP. THEREFORE, REVISION SURGERY WAS PERFORMED ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7852940 ↗