NA 1896-5047SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540382351), received between May 29, 2018 and Apr 3, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "GAMMA 3 IMPLANTED 16 MONTHS AGO AND 100 DAYS LATER THE IMPLANT BROKE. SCREWS AT THE BOTTOM BROKE AND NAIL ALSO BROKE BY THE POINT WHERE THE LAG SCREW IS IMPLANTED. ENTIRE CONSTRUCT WAS REVISED AND PATIENT EXPERIENCED A SIMILAR EVENT 100 DAYS LATER."

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

  MAUDE report 19038221 ↗
• InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POSTOPERATIVE CT REVEALED AN AVULSION FRACTURE OF THE MEDIAL CORTICAL BONE AT THE INSERTION SITE OF A LOCKING SCREW WITH DISTAL OF THE LONG GAMMA NAIL. REVISION SURGERY IS NOT PLANNED AT THIS TIME.

  Patient problems: Bone Fracture(s)

  MAUDE report 12377661 ↗
• InjuryOct 16, 2020Fracture; Fracture

  THE CUSTOMER REPORTS THE FOLLOWING: MATERIAL BREAKAGE WITHOUT EXTERNAL INFLUENCE. THE PATIENT IS ANNOUNCED TO US BY THE (B)(6) WITH ANOTHER PERIPROSTHETIC FEMUR FRACTURE ON THE LEFT SIDE. THE PATIENT HAD FALLEN ON THE STAIRS WHILE CLEANING AT HOME ON (B)(6) 2020 AND SUFFERED A SUBTROCHANTERIC FEMUR FRACTURE ON THE LEFT SIDE. SHE WAS TREATED AS DESCRIBED ABOVE ON (B)(6) 2020 AT THE (B)(6). THE INTRA- AND POSTOPERATIVE COURSE WAS UNREMARKABLE. THE PATIENT UNDERWENT A REHABILITATION MEASURE, WHICH ALSO DID NOT SHOW ANY ABNORMALITIES. DURING THE LAST WEEKS, INCREASING COMPLAINTS ON THE LEFT SIDE WITH GROIN PAIN DEVELOPED. FOR A FEW DAYS NOW, THE SYMPTOMS HAVE BEEN INCREASING SIGNIFICANTLY. THE PATIENT DID NOT FALL AGAIN. SHE HAS ALREADY HAD PROBLEMS WALKING FOR SEVERAL WEEKS, AND STRESS-RELATED PAIN. IN FURTHER DIAGNOSTICS, THE PERI-IMPLANT FRACTURE WITH OF THE IMPLANTED GAMMA NAIL ON THE LEFT SIDE IS SHOWN AND THE PATIENT IS TRANSFERRED TO OUR CLINIC. REMOVAL OF MATERIAL AND REOSTEOSYNTHESIS USING PFN 340/12 IN DOMO.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain; Limb Fracture

  MAUDE report 10690772 ↗
• InjuryJun 23, 2020Fracture; Fracture

  AS REPORTED: FIRST OPERATION ON (B)(6) 2019. ON (B)(6) 2020, CUSTOMER CONFIRMED THE DEFORMATION OF THE SCREW BY X-RAY, BUT CUSTOMER DID NOT DOUBT THAT IT WAS BROKEN, AND THEY FOLLOWED IT. A SCREW BREAKAGE WAS FOUND ON (B)(6) 2020, BUT THE PATIENT WAS FOLLOWED UP AFTER CONSULTATION WITH THE PATIENT. FALSE JOINTS WERE CONFIRMED ON (B)(6) 2020. TWO 47.5 MM SCREWS INSTALLED DISTALLY, THE PROXIMAL SIDE WAS BROKEN. THE OTHER SCREW MAY ALSO BREAK, SO THE CUSTOMER DECIDED TO PERFORM A REVISION.

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

  MAUDE report 10186454 ↗
• InjuryJun 23, 2020Fracture; Material Deformation; Fracture; Material Deformation

  AS REPORTED: FIRST OPERATION ON (B)(6) 2019. ON (B)(6) 2020, WE CONFIRMED THE DEFORMATION OF THE SCREW BY X-RAY, BUT WE DID NOT DOUBT THAT IT WAS BROKEN, AND WE FOLLOWED IT. A SCREW BREAKAGE WAS FOUND ON (B)(6) 2020, BUT THE PATIENT WAS FOLLOWED UP AFTER CONSULTATION WITH THE PATIENT. FALSE JOINTS WERE CONFIRMED ON (B)(6) 2020. TWO 47.5 MM SCREWS INSTALLED DISTALLY, THE PROXIMAL SIDE WAS BROKEN. THE OTHER SCREW MAY ALSO BREAK, SO WE DECIDED TO PERFORM A REVISION.

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

  MAUDE report 10186452 ↗
• InjuryApr 15, 2020Fracture; Fracture

  AS REPORTED: "AFTER FIXATION OF T2GTN, THE DISTAL SCREW BROKE." ADDITIONALLY REPORTED: "THE REVISION WAS MADE ON (B)(6), AND ALL NAIL AND SCREWS WERE REMOVED. SINCE BONE FUSION WAS OBTAINED, IT WAS ONLY REMOVAL."

  Patient problems: Failure of Implant; Injury

  MAUDE report 9965565 ↗
• InjuryMay 29, 2018Use of Device Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT'S RIGHT TIBIA WAS REVISED AFTER PATIENT WALKED ON THE ROD AND DISPLACED IT. REP REPORTED THAT HE HAS NO ACCESS TO ANY ADDITIONAL INFORMATION DUE TO NOT BEING ALLOWED ACCESS TO THE HOSPITAL'S PASSWORD-PROTECTED SYSTEMS. REP REPORTED THAT THE NAIL AND 5 SCREWS (3 PROXIMAL, 2 DISTAL) WERE EXPLANTED. HOSPITAL IMPLANT SHEET SHOWS A NAIL AND 6 SCREWS. ADDITIONAL INFO RECEIVED FROM REP'S EMAIL: THERE WAS A SCREW EXCHANGE FROM THE PRIMARY SURGERY DUE TO LENGTH. ONLY 5 SCREWS WERE IMPLANTED. IN INITIAL SURGERY, A 6TH SCREW WAS USED BUT IMMEDIATELY TAKEN OUT. HE DOES NOT KNOW WHICH SCREWS WERE USED AND WHICH ONE WAS NOT USED. THE DISTAL TIBIA DISPLACED NOT THE TIBIAL ROD. ADDITIONAL INFO RECEIVED FROM PHONE CALL WITH REP: REVISION NEEDED BECAUSE "PATIENT WALKED ON LEG WHEN SHOULDN'T HAVE" AND THE BONE MOVED. SURGEON FELT THAT PLATES GAVE A BETTER REDUCTION, SO HE SWITCHED FROM THE NAILING SYSTEM TO PLATING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7551265 ↗