GAMMA 3130-2170SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540375148), received between Nov 15, 2018 and Oct 25, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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.

• InjuryOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "AFTER SURGERY, THE U-LAG SCREW CUT OUT THE FEMORAL HEAD WITH U-BLADE DEFORMATION AND THE REVISION SURGERY WAS PERFORMED."

  Patient problems: Perforation

  MAUDE report 18001391 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING INSERTION OF THE NAIL, A FRACTURE OCCURRED AT ANOTHER SITE. IT WAS DETERMINED THE SURGERY COULD BE CONTINUED AND THE PROCEDURE WAS COMPLETED AS PLANNED. NO TREATMENT WAS PERFORMED FOR THE SUBTROCHANTERIC FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 12478236 ↗
• InjuryMar 12, 2019Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE GAMMA NAIL (3130-2170S) WAS INSERTED ABOUT ONE YEAR BEFORE. THE DISTAL OF THE NAIL WAS BROKEN AND IT WAS REVISED TO GAMMA LONG NAIL AT (B)(6) 2019. AT REVISION SURGERY, IT WAS 130° NAIL TO DETAIN, BUT ONLY THE 125° NAIL WAS PREPARED. THE REASON OF THIS EVENT WAS MISCOMMUNICATION OF SURGEON AND SR. SURGERY STOPPED ABOUT 90 MIN WITH ANESTHESIA ON THE PATIENT TO WAIT FOR THE ARRIVAL OF THE IMPLANT. AFTER THAT, THE SURGERY WAS FINISHED WITH NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8414661 ↗
• InjuryNov 15, 2018Patient-Device Incompatibility

  CUT OUT OF U LAG SCREW OCCURS. PATIENT FELT PAIN ON HIS HIP FOR SEVERAL WEEKS AND DIFFICULT TO WALK. THEN, WHEN FALLING ON (B)(6), VISITED IN THE HOSPITAL AND AN X - RAY FILM WAS TAKEN, IT TURNED OUT THAT THE LAG SCREW HAD CUT OUT AND REACHED THE ACETABULAR. THERE IS NO DISLOCATION OF THE PIECES OF THE BONY SKULL, AND ONLY THE LAG SCREW HAS CUT OUT. AS A MEASURE AFTER OCCURRENCE, ON (B)(6) REPLACED 120 ° GAMMA NAIL.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 8074995 ↗