GAMMA 3130-1200SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540375131), received between Sep 4, 2015 and Feb 28, 2022 — classified as 6 injuries, 1 malfunction.

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

• MalfunctionFeb 28, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  EXCESSIVE FORCE WAS USED FOR THE INSERTION OF THE CEPHALIC SCREW, IT WAS NOTICEABLE THAT IT DID NOT SLIDE WELL INSIDE THE NAIL. IT WAS CHECKED THAT EVERYTHING WAS WELL CONNECTED. NAIL AND SCREW WAS DISASSEMBLED AND REASSEMBLED OUTSIDE, IT CONTINUED TO RUB AGAINST THE CEPHALIC SCREW WHEN PASSING INSIDE OF THE NAIL. A NEW NAIL AND SCREW WAS USED AT THE END. THERE WAS A DELAY OF 1 HOUR DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13619684 ↗
• InjuryDec 20, 2019Fracture; Fracture

  THE GAMMA3 NAIL BROKE AND WAS REPLACED BY AN ARTIFICIAL HIP JOINT IN (B)(6) 2019.

  Patient problems: Failure of Implant; Injury

  MAUDE report 9507539 ↗
• InjuryOct 23, 2019Difficult or Delayed Positioning; Loose or Intermittent Connection; Migration or Expulsion of Device; Difficult or Delayed Positioning

  THE GAMMA 3 FEMORAL NECK SCREW HAS COME LOOSE AND HAS MIGRATED INTO THE PELVIS.

  Patient problems: Injury; No Known Impact Or Consequence To Patient

  MAUDE report 9226582 ↗
• InjuryAug 7, 2018Break

  PATIENT CAME IN WITH PAIN IN THE RIGHT HIP. X-RAY CONTROL SHOWED A BREAKAGE OF THE GAMMA NAIL.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7757223 ↗
• InjuryAug 2, 2018Fracture

  THE PATIENT WAS TREATED ON (B)(6) 2018 WITH THE GAMMA NAIL AFTER THE PATIENT FELL AND HAD A PERTROCHANTERIC FEMUR FRACTURE. AFTER INITIALLY INCONSPICUOUS COURSE, IT CAME ON (B)(6) 2018 WITHOUT TRAUMA TO A FRACTURE OF THE GAMMA NAIL. AS A RESULT THE PATIENT NEEDS TO BE TREATED AGAIN ON (B)(6) 2018. HERE WAS THE EXPLANTATION OF THE GAMMA NAIL AND THE RENEWED SUPPLY WITH ANOTHER STRYKER NAIL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7744425 ↗
• InjurySep 23, 2015Break

  IT IS REPORTED BY THE SURGEON OF THE HOSPITAL, THAT A PATIENT CAME IN WITH PAIN. HE TOOK AN XRAY AND IT IS OBSERVED THAT THE G3 NAIL IS BROKEN. REVISION SURGERY WILL TAKE PLACE ON (B)(6) 2015.

  Patient problems: No Code Available

  MAUDE report 5096934 ↗
• InjurySep 4, 2015Break

  IT IS REPORTED BY THE SURGEON OF THE HOSPITAL, THAT THE PATIENT WAS ACCOMMODATE IN HOSPITAL WITH SUSPECTED PSEUDOARTHROSES LEFT AFTER GAMMA IMPLANTATION IN (B)(6) 2015. IN A NEW MEDICAL PROCEDURE THE SURGEON NOTICED THAT THE NAIL WAS BROKEN. A DHS WAS IMPLANTED.

  Patient problems: No Information

  MAUDE report 5055708 ↗