GAMMA 3430-1360SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613252273981), received between Jun 25, 2019 and Jul 29, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2024Break; Fracture; Break; Fracture

  AS REPORTED, IT WAS DECIDED FOR A NAIL/SCREW REMOVAL DUE TO NAIL GAMMA 3 BREAKAGE. IMPLANT DATE (B)(6) 2024. (NORMAL WEIGHT PATIENT).

  Patient problems: Failure of Implant

  MAUDE report 19849878 ↗
• InjuryJul 3, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "SURGERY AND IMPLANTATION OF NAIL ON (B)(6) 2022. ACCORDING TO PATIENT NAIL BROKEN IN LESS THAN 6 MONTHS."

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

  MAUDE report 17253245 ↗
• InjuryMay 11, 2021Fracture; Fracture

  THE CUSTOMER REPORTED THAT THE GAMMA NAIL WHICH HAD BEEN IMPLANTED ON (B)(6) FAILED.

  Patient problems: Failure of Implant

  MAUDE report 11807109 ↗
• InjuryJun 25, 2019Fracture

  CONCERNS (B)(6), COGNITIVE GOOD. VG / OSTEOPOROSIS AFTER CHRONIC PREDNISONE USE AND 10J BISPHOSPHONATES. ON (B)(6) 2018 OPERATION 1, OTHER OPERATOR, COMMINUTED SUBTROCHANTERIC FEMORAL SHAFT FRACTURE WITH LARGE SHARD MEDIAL OPEN REPOSITION AND CERCLAGES, PLACEMENT OF LONG GAMMA NAIL 125GR FOLLOWED BY TWINING OF CERCLAGES. NO SPECIFIC PROBLEMS MENTIONED. BY APPOINTMENT OPERATOR 100% LOADED MOBILIZATION FROM INTERVENTION, INITIALLY NO PROBLEMS WITH LOADING. UNCOMPLICATED COURSE, WOUND HEALING. ON (B)(6) 2019: WITHOUT TRAUMA SUDDENLY TO BURDEN PAIN AND INABILITY, BROKEN GAMMA NAIL ON COLLUM HOLE AND REDISLOCATION, NO SIGNS INFECTION. ON (B)(6) 2019: OPERATION 2: REMOVING THE PEN AND SCREWS, NO SPECIFIC FEATURES, POSSIBLE SHARPENED COLLUM-HOLE PIN BOT REVIVES, PLACES DBX (GF) AND SPONGIOSA, PLACES NEW EXTENDED GAMMA NAIL 130GR, UNCOMPLICATED. PEROPERATIVE CULTURES NEGATIVE. THIS IS REPORTED IN PER (B)(4). ON (B)(6) 2019: GAMMA NAIL BROKEN AGAIN.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 8732801 ↗