GAMMA 3066-0090SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04546540595980), received between Jan 30, 2017 and Aug 28, 2024 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: POSTOPERATIVELY, A CUTOUT OCCURRED REQUIRING REVISION SURGERY.

  Patient problems: Perforation

  MAUDE report 20092438 ↗
• InjuryAug 15, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "THE GAMMA3 U-BLADE LAG SCREW WAS IMPLANTED IN THE LEFT FEMUR IN 2017. BECAUSE THE PATIENT HAD NOT VISITED THE HOSPITAL AFTER DISCHARGE, THE FOLLOW-UP MEDICAL EXAMINATION WAS NOT PERFORMED. ON (B)(6) 2023, THE PATIENT VISITED THE OUTPATIENT DEPARTMENT OF THE HOSPITAL, AND CUTOUT OF THE LAG SCREW AND BROKEN OF THE U-BLADE WERE CONFIRMED. THE CT EXAMINATION REVEALED THAT THE PART OF THE BROKEN U-BLADE WAS LEFT IN THE PELVIS. THE REVISION SURGERY WAS PERFORMED".

  Patient problems: Failure of Implant

  MAUDE report 17548911 ↗
• MalfunctionApr 11, 2023Material Deformation; Material Deformation

  AS REPORTED: THE U-LAG SCREW CUTOUT WAS OCCURRED. THE U-BLADE HAS DEFORMED. REVISION SURGERY TO BIPOLAR WILL BE PLANNED."

  Patient problems: Perforation

  MAUDE report 16718156 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED: "DUE TO THE POSTOPERATIVE CUTOUT OF THE LAG SCREW, A REVISION SURGERY WAS PERFORMED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13509063 ↗
• InjuryDec 23, 2020Fracture; Fracture

  AS REPORTED: "THE CUSTOMER IMPLANTED A GAMMA3 NAIL WITH A U-BLADE SHS IN A PATIENT. THIS (U-BLADE) IS BROKEN IN THE PATIENT. AFTER THE SURGEON HAS REMOVED THE NAIL AGAIN, THE PATIENT REQUESTS AN EXAMINATION OF THE IMPLANT." ADDITIONAL INFORMATION RECEIVED THROUGH THE X-RAYS: THE LAG SCREW OF THE U-BLADE SET IS BROKEN IN THE PATIENT.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 11069934 ↗
• InjuryAug 7, 2020Migration; Migration

  AS REPORTED: LEFT FEMORAL TROCHANTERIC FRACTURE. ON (B)(6) 2019 GAMMA3 SURGERY. SHE RECOVERED STEADILY AFTER SURGERY, BUT SUDDENLY SHE WAS UNABLE TO WALK. THE LAG SCREW WAS CUT OUT WHEN THE X-RAY WAS TAKEN. (B)(6) 2020 REVISION PLAN TO CHANGE TO BIPOLAR.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Injury

  MAUDE report 10379929 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  AS REPORTED: "AFTER TREATMENT WITH A GAMMA NAIL FOR A CERVICAL FRACTURE, THE LAG SCREW EXCESSIVELY TELESCOPED TO A CUTOUT. SURGEON THINK THERE IS A POSSIBILITY THAT THE SET SCREW DID NOT FIT INTO THE LAG SCREW." REVISION SURGERY OCCURRED AS A RESULT.

  Patient problems: Injury

  MAUDE report 9521816 ↗
• MalfunctionApr 4, 2019Difficult to Insert

  IT WAS REPORTED THAT, WHEN USING THE U LAG SCREW, THE U BLADE WAS INSERTED MANUALLY INTO THE FLUTE OF THE U LAG SCREW, THE U BLADE COULD NOT BE INSERTED TO THE OPTIMUM POSITION. THE SET SCREW WAS LOOSENED, THE U LAG SCREW WAS REVERSELY ROTATED (PULLED BACK), AND THE U BLADE WAS PROTRUDED FROM THE OUTER CORTICAL BONE AGAIN TO TRY INSERTING THE U BLADE MANUALLY, BUT THIS COULD NOT BE SOLVED. UNABLE TO USE U LAG SCREW, CHANGED TO GAMMA 3 LAG SCREW. NO ADVERSE CONSEQUENCES OR SURGICAL DELAY WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8483034 ↗
• InjuryDec 10, 2018Break

  AT (B)(6) 2014, THE U-LAG SCREW WAS IMPLANTED ON TROCHANTER FRACTURE. AT (B)(6) 2018, THE PATIENT FRACTURED THE FEMORAL BONE TRUNK AT THE NURSING HOME. PATIENT HAD OSTEONECROSIS OF THE FEMORAL HEAD AND THE U-BLADE WAS BROKEN AND IT WAS LEFT IN THE PELVIS. HOWEVER, THE POSSIBILITY OF THE BLADE MOVING IN THE PELVIS IS LOW BECAUSE THE PATIENT IS ELDERLY AND ALMOST BEDRIDDEN, SO THE DOCTOR WAS TO FOLLOW UP AS IT IS.

  Patient problems: Bone Fracture(s); Necrosis

  MAUDE report 8148235 ↗
• InjuryJan 30, 2017Material Perforation

  INITIAL SURGERY WAS PERFORMED ON (B)(6) 2015. BECAUSE THE PATIENT LEFT WITH INVERSION, LAG SCREW WAS INSERTED ABOVE FEMORAL HEAD CENTER ON FRONTAL PLANE. THE PATIENT VISITED TO THE HOSPITAL DUE TO FEELING OF STRANGENESS ON (B)(6) 2016. THE SURGEON FOUND THAT BONE FRAGMENT WAS INVERTED AND THE SCREW CAME NEAR TO PERFORATE THE FEMORAL HEAD BUT THE SURGEON DECIDED FOLLOW-UP. WHEN RECHECK 2 MONTHS AFTER, THE SCREW PERFORATED TO THE FEMORAL HEAD. THE PATIENT HAD THE PAIN WITH FLEXION OF THE HIP BUT BECAUSE PATIENT¿S OVERALL STATUS IS NOT GOOD, REVISION IS NOT PLANNED. THE PATIENT HAS DEMENTIA AND FELL MANY TIMES. SURGEON¿S OPINION: 3 MONTHS AFTER SURGERY, AS THE LAG SCREW WAS SLIGHTLY SLIDE, THE FUNCTION OF THE LAG SCREW AND SET SCREW WORKED WELL AND THE PATIENT COULD WALK IN STANDING POSITION A LITTLE. WHY DID THE LAG SCREW NOT SLIDE MORE? IF THE FEMORAL HEAD IS NECROSED, DOES THE LAG SCREW NOT SLIDE?

  Patient problems: Pain

  MAUDE report 6287638 ↗