GAMMA 3525-1340SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613252274278), received between Feb 18, 2020 and Jan 7, 2026 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Positioning Failure

  AS REPORTED: "THE SET SCREWS FROM THE GAMMA NAIL KIT DID NOT HOLD IN THE NAIL. AFTERWARDS, A SEPARATELY PACKAGED SET SCREW WAS OPENED, BUT THIS ONE ALSO DID NOT HOLD IN THE NAIL. SUBSEQUENTLY, A NEW NAIL WAS IMPLANTED, AND THE SET SCREW THAT CAME WITH THIS NAIL WORKED AS INTENDED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989677 ↗
• InjuryDec 22, 2025Fracture; Fracture

  AS REPORTED: "ON (B)(6) 2025, EMERGENCY ADMISSION DUE TO PAIN IN LEFT HIP; MULTIPLE FRAGMENT FEMUR FRACTURE AND OSTEOSYNTHESIS WITH GAMMA NAIL OUTWARD ON (B)(6) 2025. DIAGNOSIS: PSEUDARTHROSIS WITH IMPLANT FRACTURE IN LEFT HIP."

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

  MAUDE report 23871852 ↗
• InjuryNov 27, 2024Break; Fracture; Device Damaged by Another Device; Break; Fracture; Device Damaged by Another Device

  AS REPORTED: "NAIL BREAKAGE THROUGH THE HOLE FOR THE FEMORAL NECK SCREW. NO FURTHER ACCIDENT. THE PATIENT HAD TO BE OPERATED ON AGAIN AND FITTED WITH A HIP TP."

  Patient problems: Failure of Implant

  MAUDE report 20797361 ↗
• InjuryJul 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT A GAMMA NAIL BROKE AND A REVISION SURGERY (TEP) WAS REQUIRED. UPDATE: WHILE REVIEWING THE X-RAYS, WE CAN NOTICE THAT, THERE IS BREAKAGE OF DISTAL LOCKING SCREW AS WELL.

  Patient problems: Failure of Implant

  MAUDE report 12212982 ↗
• InjuryMar 5, 2021Fracture; Fracture

  THE CUSTOMER REPORTED THAT THE 13MM GAMMA NAIL WHICH WAS IMPLANTED APPROXIMATELY 2 MONTHS AGO WAS REVISED ON (B)(6) 2021. ADDITIONAL INFORMATION: SUDDEN ONSET OF PAIN, XRAYS SHOWED THE NAIL TO BE BROKEN THROUGH THE LAG-SCREW HOLE.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 11426256 ↗
• InjuryDec 8, 2020Fracture; Fracture

  A BROKEN NAIL IS REPORTED. THE PRIMARY SURGERY TOOK PLACE ON (B)(6) 2020 AT THE HOSPITAL IN (B)(6). THE CUSTOMER REPORTS THAT THE BREAK MUST HAVE OCCURRED BETWEEN 1ST AUGUST AND 1ST OCTOBER. THE PATIENT CAME IN WITH PAIN.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 10972461 ↗
• InjuryAug 19, 2020Fracture; Fracture

  THE NAIL BROKE. REVISION HAD TO BE PERFORMED. ADDITIONAL INFORMATION FROM THE SURGEON: "AFTER 6 WEEKS OF RELIEF AFTER IMPLANTATION OF THE NAIL, MOBILIZATION WAS STARTED. AFTER INITIALLY GOOD MOBILIZATION, INCREASING PAIN OCCURRED IN THE OPERATED HIP UP TO IMMOBILIZATION. THE FRACTURE OF THE NAIL WAS THEN IDENTIFIED RADIOLOGICALLY. THERE WAS A CHANGE TO A CEMENTED LONG-STEM PROSTHESIS."

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

  MAUDE report 10427806 ↗
• InjuryApr 6, 2020Fracture; Fracture

  AS REPORTED, GAMMA 3 NAIL BROKE THROUGH THE LAG SCREW HOLE ON THE (B)(6) 2020. THE NAIL WAS REMOVED ON THE (B)(6) 2020 AND A SYNTHES BLADE PLATE INSERTED. SURGEON THOUGHT THE TIME FROM IMPLANTATION UNTIL FAILURE FAIRLY SHORT. HE SAID THE ORIGINAL FRACTURE WAS A VERY CHALLENGING TYPE BUT IT HAD BEEN REDUCED WELL AND THE NAIL APPEARED TO BE IMPLANTED ALL IN ACCORDANCE WITH THE SURGICAL TECHNIQUE. THE ORIGINAL OPERATION WAS PERFORMED AT (B)(6) HOSPITAL.

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

  MAUDE report 9928477 ↗
• InjuryFeb 18, 2020Fracture; Fracture

  IT WAS REPORTED, A PATIENT FELL OVER & FRACTURED LEFT NECK OF FEMUR. ALREADY HAD A LONG GAMMA NAIL IN HIP WHICH FRACTURED AT SITE OF LAG SCREW. OPERATION FOR REMOVAL OF BROKEN NAIL & INSERTION OF 13 MM LONG GAMMA NAIL.

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

  MAUDE report 9721683 ↗