GAMMA 3420-0280SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540375186), received between Nov 16, 2018 and Feb 10, 2022 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "PATIENT FELL ON (B)(6) 2022 AND DEVELOPED PAIN. THE PATIENT WAS EXAMINED ON (B)(6) AND IT WAS FOUND THAT THE IMPLANT WAS BROKEN AND THE FRACTURE WAS DISLOCATED. THE FRACTURE WAS PSEUDO ARTICULAR, BUT THE PATIENT WAS TOO OLD, SO ONLY THE IMPLANT REMOVAL WAS DONE."

  Patient problems: Fall; Implant Pain

  MAUDE report 13508167 ↗
• InjuryDec 10, 2021Break; Break

  AS REPORTED: "THE NAIL WAS BROKEN OFF AT THE LAG SCREW HOLE DUE TO PSEUDOARTHROSIS." DEVICE EXPLANTATION OF THE DEVICE WAS PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 12976145 ↗
• InjuryNov 16, 2018Insufficient Device Problem Information

  ON (B)(6) 2018: REMOVAL OF NAIL REMAINED IN THE PATIENT'S BODY WAS DONE. HOWEVER, THE DISTAL PART OF THE NAIL WAS NOT REMOVED AND IT WAS LEFT AND CHS IMPLANT (SYNTHES) WAS DEPLOYED. REV # 2.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8081334 ↗
• InjuryNov 16, 2018Break; Material Twisted/Bent

  AT (B)(6) 2018, OPERATION WAS DONE WITH LONG GAMMA NAIL. AT (B)(6) 2018, SUDDENLY SHE FELT A PAIN WHEN SHE WAS GOING DOWN THE HILL. THEREFORE, SHE VISITED THE HOSPITAL AND CONFIRMED BREAKING OF THE NAIL AROUND THE LAG SCREW HOLE. AT (B)(6) 2018, REVISION SURGERY IS PLANNED. AFTER THE PROXIMAL BROKEN NAIL AND LAG SCREW WERE REMOVED, EXTRACTION HOOK (18066160) WAS HANGED TO THE DISTAL PART OF NAIL AND HIT WITH HAMMER AND ABOUT 1MM OF THE TIP OF THE EXTRACTION HOOK WAS LACKED AND THE IT WAS NOT ABLE TO BE HANGED TO NAIL. THEREFORE, NEW HOOK WAS USED, BUT THE TIP OF THE HOOK WAS BENT AFTER IT WAS HIT WITH HAMMER AND NOT ABLE TO BE USED. THEREFORE, THE DISTAL PART OF THE NAIL AND BROKEN HOOK WAS LEFT IN THE PATIENT BODY AND OPERATION WAS FINISHED. REMOVAL OF NAIL REMAINED IN THE PATIENT'S BODY WAS DONE. HOWEVER, THE DISTAL PART OF THE NAIL WAS NOT REMOVED AND IT WAS LEFT AND CHS IMPLANT (SYNTHES) WAS DEPLOYED. REVISION # 2 REPORTED UNDER SEPARATE PI.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8081152 ↗