GAMMA 8425-1420SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327478785), received between Feb 18, 2025 and Jun 29, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Fracture” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2026Fracture

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT SURGERY ON (B)(6) 2026, FOR A COMPLEX FRACTURE OF THE PROXIMAL FEMUR, TREATED WITH A LONG GAMMA4 NAIL. HE REMAINED NON-WEIGHT-BEARING FOR SIX WEEKS. A FOLLOW-UP X-RAY PERFORMED AT THAT TIME CONFIRMED THAT THE REDUCTION WAS STABLE AND THAT HEALING HAD BEGUN. WEIGHT-BEARING WAS THEN PERMITTED. HOWEVER, JUST ONE MONTH AFTER RESUMING WEIGHT-BEARING, THE PATIENT EXPERIENCED A FRACTURE OF THE OSTEOSYNTHESIS HARDWARE. UPON REVIEW OF THE PROVIDED X-RAYS, DEFORMATION OF ONE LOCKING SCREW WAS IDENTIFIED. HE WILL UNDERGO REOPERATION ON JUNE 8 FOR A COMPLEX REVISION PROCEDURE INVOLVING THE REMOVAL OF THE FRACTURED NAIL, FOLLOWED BY A NEW OSTEOSYNTHESIS USING A LONG DCS PLATE COMBINED WITH A BONE GRAFT.

  Patient problems: Insufficient Information

  MAUDE report 25658435 ↗
• InjuryMar 30, 2026Fracture

  AS REPORTED: "REMOVAL OF A BROKEN LONG GAMMA 4 NAIL (AT THE CERVICAL SCREW) IN SITU, REQUIRING THE FITTING OF A HIP PROSTHESIS. THE NAIL HAD BEEN FITTED ON (b)(6)2025."20-MAR-2026 - ADDITIONAL INFORMATION RECEIVED:IT WAS DETECTED VIA AN X-RAY OF THE HIP AND PELVIS IN THE EMERGENCY DEPARTMENT. THE X-RAY WAS PERFORMED ON A PATIENT WHO HAD BEEN EXPERIENCING PAIN AND WEAKNESS IN THE LOWER LIMB THAT HAD GRADUALLY DEVELOPED OVER THE PAST 5 DAYS. (THE PATIENT HAD UNDERGONE SURGERY FOR A TRANSFEMORAL FRACTURE OF THE FEMUR IN (b)(6) 2025.)A NEW OPERATION WAS REQUIRED TO REMOVE THE BROKEN NAIL AND IMPLANT A HIP PROSTHESIS.16-APR-2026 - ADDITIONAL INFORMATION RECEIVED:O HOW AND WHEN DID THE PATIENT BECOME AWARE OF THE EVENT? 73-YEAR-OLD PATIENT PRESENTING WITH PROGRESSIVE RIGHT HIP PAIN FOR 5 DAYS. FELL ON (b)(6)2026 WITHOUT LOSS OF CONSCIOUSNESS OR TRAUMA. DIAGNOSED WITH A NAIL FRACTURE IN THE EMERGENCY DEPARTMENT ON (b)(6)2026.

  Patient problems: Fall; Pain

  MAUDE report 24710385 ↗
• InjuryDec 22, 2025Fracture; Fracture

  AS REPORTED: "ON TUESDAY 25/11/25 I RECEIVED A MESSAGE TO COME IN AND SUPPORT A CASE TO REMOVE A BROKEN GAMMA NAIL. THE SURGEON DOING THE REVISION CASE WAS BOOPALAN RAMASAMY. THE PLAN WAS TO REMOVE THE BROKEN NAIL, USE THE SYNTHEES RIA REAMER TO TRY AND PREVENT ANY INFECTION AND THEN RE-FIXATE THE FRACTURE WITH A SMITH AND NEPHEW NAIL. ORIGINAL CASE DATE FOR IMPLANTATION OF THE GAMMA NAIL WAS (B)(6) 2025."

  Patient problems: Insufficient Information

  MAUDE report 23869632 ↗
• InjuryJul 1, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "GAMMA 4 LONG NAIL BROKE AT THE LAG SCREW.".

  Patient problems: Insufficient Information

  MAUDE report 22375916 ↗
• InjuryMar 14, 2025Break; Fracture; Device Damaged by Another Device; Break; Fracture; Device Damaged by Another Device

  AS REPORTED: "I WAS MADE AWARE THIS MORNING OF A GAMMA 4 REVISION SCHEDULED FOR TOMORROW THE INITIAL SURGERY WAS (B)(6) 2024. THE IMPLANTS IS BROKEN ABOVE THE LAG SCREW AND THE PATIENT IS NOW IN FOR A PROXIMAL FEMORAL REPLACEMENT.". PATIENT HAD PAIN IN THE HIP. PATIENT HAS A HISTORY OF TUMOURS.

  Patient problems: Pain

  MAUDE report 21608799 ↗
• InjuryFeb 18, 2025Break; Fracture; Device Damaged by Another Device; Break; Fracture; Device Damaged by Another Device

  AS REPORTED BY THE REP: GAMMA 4 REVISION CASE, DUE TO A NONUNION AND IMPLANT BREAKAGE.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21399345 ↗