NA 1896-5060SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04546540202536), received between May 29, 2018 and Sep 4, 2025 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "DISTAL LOCKING SCREW BACKED OUT FROM PATIENT GAMMA3 NAIL. ORIGINAL CASE WAS ON (B)(6) 2025, REVISION WAS ON (B)(6) 2025. SURGEON THEORIZES IT WAS BECAUSE HE HAMMERED THE SCREW IN. REVISION SURGERY. HAD TO UNDERGO SECOND SURGERY TO REVISE SCREW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22962092 ↗
• InjuryApr 5, 2024Biocompatibility; Biocompatibility

  THE CUSTOMER REPORTED THAT "PATIENT PRESENTING WITH CHRONIC GENERALIZED URTICARIA SINCE NOVEMBER 2022 AND AFTER THE INSTALLATION OF OSTEOSYNTHESIS MATERIAL. "

  Patient problems: Urticaria

  MAUDE report 19051014 ↗
• MalfunctionJan 4, 2022Inaccurate Information; Inaccurate Information

  STRYKER REP REPORTED THAT SCREWS MEASURING SHORTER THAN THE DESCRIBED LENGTH. SCREW WAS IMPLANTED AND THEN REMOVED DUE TO BEING TO SHORT. A DIFFERENT SCREW WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS DELAYED BY 15 MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13156239 ↗
• InjuryJul 31, 2020Fracture; Fracture

  THE CUSTOMER REPORTED THAT THE GAMMA NAIL BROKE REQUIRING REVISION. LOCKING SCREWS ALSO BROKE. INITIAL IMPLANT ON (B)(6) 2020. REVISION SURGERY WAS UNDERTAKEN ON (B)(6) 2020. MOBILISATION INSTRUCTIONS: MOBILISATION AS TOLERATED. PATIENT MOBILISED WELL WITH STICK AFTER BEING DISCHARGED FROM PRIMARY OP. USES STICK SOMETIMES WHEN OUTSIDE BUT DOES NOT USE STICK INDOORS. NO TRAUMA.

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

  MAUDE report 10351249 ↗
• InjuryJul 27, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT FEMUR WAS REVISED DUE TO THE NAIL BREAKING AT THE JUNCTION OF THE LAG SCREW, WHICH THEN LED TO TWO DISTAL SCREWS BREAKING. REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Injury

  MAUDE report 10329683 ↗
• MalfunctionApr 14, 2020Break; Break

  AS REPORTED: "THE LOCKING SCREW WAS UNABLE TO BE INSERTED. THE DRILL DIAMETER WAS ALSO CHECKED AND DIGGING THE TARGET SITE AGAIN, BUT IT WAS STILL UNABLE TO BE INSERTED. SINCE IT WAS FORCEFULLY ATTEMPTED TO INSERT, THE SCREW WAS SHAPED (BROKEN). THE SCREW WAS THEN REPLACED WITH NEW ONE BUT THE SAME EVENT OCCURRED. THE SURGEON STATED THAT THE EVENT OCCURRED DUE TO BONE QUALITY (HARD BONE)."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9960738 ↗
• MalfunctionApr 14, 2020Break; Break

  AS REPORTED: "THE LOCKING SCREW WAS UNABLE TO BE INSERTED. THE DRILL DIAMETER WAS ALSO CHECKED AND DIGGING THE TARGET SITE AGAIN, BUT IT WAS STILL UNABLE TO BE INSERTED. SINCE IT WAS FORCEFULLY ATTEMPTED TO INSERT, THE SCREW WAS SHAPED (BROKEN). THE SCREW WAS THEN REPLACED WITH NEW ONE BUT THE SAME EVENT OCCURRED. THE SURGEON STATED THAT THE EVENT OCCURRED DUE TO BONE QUALITY (HARD BONE)."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9960715 ↗
• InjuryMay 29, 2018Device 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 Code Available

  MAUDE report 7551262 ↗