NA 1896-5050SRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 04546540202512), received between Sep 9, 2015 and Feb 9, 2026 — classified as 28 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (19 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2026Fracture; Device Damaged by Another Device

  IT WAS REPORTED THAT A GAMMA 3 LONG NAIL BROKE. ADDITIONALLY, 2 BROKEN SCREWS WERE ALSO REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24293522 ↗
• InjuryOct 9, 2025Fracture; Fracture

  AS REPORTED: "PATIENT WAS IMPLANTED WITH A 9MM 380MM T2 FEMORAL NAIL WHICH VERY RECENTLY FAILED WITH FRACTURED DISTAL LOCKING SCREWS AND FRACTURED PROXIMAL PORTION OF NAIL, BROKEN IMPLANT WAS REMOVED AND REVISED WITH A 11MM 360MM T2 ALPHA NAIL."

  Patient problems: Insufficient Information

  MAUDE report 23253722 ↗
• InjuryAug 14, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THE NAIL, FITTED TO A PATIENT FOLLOWING A POLYFRAGMENTED STEPPED FRACTURE OF THE RIGHT FEMORAL SHAFT ON (B)(6) 2022 (PATIENT SIGNIFICANTLY OVERWEIGHT 130KG), BROKE AND HAD TO BE REMOVED. IN THE CHRONOLOGY OF EVENTS, WE CAN REPORT THE FOLLOWING: ON (B)(6) 2022: DISPLACEMENT OF THE DISTAL LOCKING SCREWS DURING MARKET RESUMPTION ON (B)(6) 2023: COMPLETE BREAKAGE OF THE DISTAL LOCKING SCREWS, TELESCOPING OF THE FRACTURE SITE WITH THE DISTAL PART OF THE NAIL BEING DRIVEN INTO THE MEDIAL CONDYLE OF THE RIGHT KNEE ON (B)(6) 2024: INCOMPLETE BREAKAGE OF THE PROXIMAL PART OF THE GAMMA LONG NAIL AND SCHEDULING OF A REOPERATION FOR NAIL EXTRACTION. ON (B)(6) 2025: NAIL EXTRACTION."

  Patient problems: Insufficient Information; Nonunion/Delayed-union Bone Fracture

  MAUDE report 22803499 ↗
• InjuryAug 13, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THE PATIENT WAS IMPLANTED WITH THE LONG GAMMA3 NAIL DESCRIBED ABOVE ON (B)(6) 2024 FOR A SUBTROCHANTERIC FRACTURE ON THE LEFT. HE WAS ABLE TO BE MOBILIZED UNDER FULL WEIGHT-BEARING DURING THE PROCEDURE. A FRACTURE OF THE LONG GAMMA NAIL WAS DIAGNOSED DURING A FOLLOW-UP X-RAY EXAMINATION, WHICH WAS PERFORMED DUE TO PAIN. ON (B)(6) 2025, REVISION SURGERY WAS PERFORMED WITH EXPLANTATION OF THE BROKEN GAMMA 3 NAIL ON THE LEFT." (B)(6) 2025 - DURING FULL PRODUCT INSPECTION, IT TURNED OUT THAT A TINY PART OF LOCKING SCREW TIP IS BROKEN.

  Patient problems: Pain

  MAUDE report 22796509 ↗
• InjuryJul 8, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A CASE OF SUBCONDYLAR FRACTURE WAS TREATED WITH GAMMA 3 NAILS, BUT A PSEUDOARTHROSIS OCCURRED AND THE NAILS AND SCREWS WERE BROKEN OFF. THE PATIENT WAS REPLACED WITH A NAIL FROM ANOTHER COMPANY ON (B)(6). NAIL HAS A BROKEN LAG SCREW HOLE SECTION, AND TWO LOCKING SCREWS WERE ALSO BROKEN.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 22444514 ↗
• InjuryApr 5, 2024Biocompatibility; Biocompatibility

  THE CUSTOMER REPORTED THAT "PATIENT PRESENTING WITH CHRONIC GENERALIZED URTICARIA SINCE (B)(6) 2022 AND AFTER THE INSTALLATION OF OSTEOSYNTHESIS MATERIAL."

  Patient problems: Urticaria

  MAUDE report 19051011 ↗
• MalfunctionJun 22, 2023Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT AN EXPIRED SCREW HAD BEEN USED DURING THE GAMMA NAIL CASE ON (B)(6) 2023 . THE IMPLANT IS A 5X50MM LOCKING SCREW REF 1896-5050S LOT: K0BF71A WITH AN EXPIRY DATE OF 31/03/2023. DURING THE SURGERY THE SALES REP DID NOT ATTEND THE CASE BECAUSE OF COVID AND THE CASE WENT ON ITS OWN. THE IMPLANT WAS OPENED BY THE NURSE ON DUTY THAT DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17183200 ↗
• InjuryNov 29, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A GAMMA NAIL BROKEN AND HAD TO BE EXPLANTED. UPON PRODUCT RETURN, ONE LOCKING SCREW WAS FOUND BROKEN.

  Patient problems: Failure of Implant

  MAUDE report 15875971 ↗
• InjuryAug 19, 2022Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED A BROKEN GAMMA3 NAIL (3525-0360S). "THE PATIENT WAS TREATED EXTERNALLY FOR A PER/SUBTROCHANTERIC LEFT FEMUR FRACTURE ON (B)(6) 2021 WITH A WITH A GAMMA NAIL. DURING THE CONSULTATION (B)(6) 2022, THE IMPLANT FRACTURE WAS DIAGNOSED AND THE PATIENT WAS ADMITTED TO HIP CLINIC AT BALGRIST UNIVERSITY HOSPITAL FOR FURTHER TREATMENT. HERE THE INDICATION FOR REVISION WAS GIVEN IN CASE OF SYMPTOMATIC PSEUDARTHROSIS. THE INDICATION FOR REVISION WAS GIVEN AND THE PATIENT HAD TO UNDERGO SURGERY ON (B)(6) 2022." 7/22/2022 - ADDITIONAL INFORMATION: UPON PRODUCT RETURN, ONE LOCKING SCREW WAS FOUND BROKEN.

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

  MAUDE report 15260489 ↗
• InjuryAug 19, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT GAMMA NAIL AND SCREW BROKE. IMPLANTATION TOOK PLACE IN MAY 2022. PATIENT STATED TO THE PHYSICIAN THAT HE HAD FOLLOWED THE PHYSICIAN'S INSTRUCTIONS, BUT HAD NOTICED PAIN WHILST WALKING. EXPLANTATION AND SIMULTANEOUS IMPLANTATION OF A NEW GAMMA3 NAIL.

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

  MAUDE report 15260046 ↗
• MalfunctionAug 18, 2022Device Difficult to Setup or Prepare; Difficult to Advance; Device Difficult to Setup or Prepare; Difficult to Advance

  IT WAS REPORTED THAT THERE WAS A FAILURE WITH THE T2 FEMUR SCREW 5,5MM. THE SCREW DIDN'T ROTATE IN THE NAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15255177 ↗
• InjuryJul 21, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON (B)(6) 2021 THE PATIENT TRIPPED AND FELL AND ON (B)(6) 2021 SHE PRESENTED FOR TREATMENT AND WAS DIAGNOSED WITH A RIGHT SUBTROCHANTERIC FEMUR FRACTURE. ALLEGEDLY ON (B)(6) 2021 SHE UNDERWENT AN INTRAMEDULLARY NAIL FIXATION AND CERCLAGE WIRING IN THE SUBTROCHANTERIC REGION UTILIZING GAMMA 3. ALLEGEDLY ON (B)(6) 2021 THE PATIENT DEVELOPED SUDDEN ONSET OF SEVERE PAIN IN THE RIGHT HIP AND IT WAS NOTED THE PROXIMAL ASPECT OF THE ROD WAS FRACTURED AT THE LOCATION OF THE PROXIMAL COMPRESSION SCREW AND DISTAL INTERLOCKING SCREW WAS FRACTURED. REVISION SURGERY WAS PERFORMED ON (B)(6) 2021.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 15072816 ↗
• InjuryMar 30, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "THE PATIENT UNDERWENT EMERGENCY SURGERY ON (B)(6) 2022 AND RETURNED TO THE EMERGENCY ROOM ON (B)(6) 2022 PRESENTING PAIN AND DIFFICULTY IN LOCOMOTION IN WHICH AFTER X-RAY IT WAS EVIDENCED THAT THE DISTAL SCREW WAS BROKEN."

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

  MAUDE report 13951405 ↗
• InjuryFeb 14, 2022Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED A BROKEN GAMMA NAIL WHICH REQUIRES REVISION. UPDATE: NON UNION IN PATIENT. UPON RETURN OF THE DEVICES, ONE OF THE LOCKING SCREW WAS FOUND BROKEN.

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

  MAUDE report 13523229 ↗
• InjuryAug 17, 2021Fracture; Fracture

  IT WAS REPORTED THE DEVICES 1891-5050S AND 1986-5050S WERE BROKEN DUE TO NON-UNION, BUT WERE SUCCESSFULLY REMOVED ALONG WITH OTHER RETAINED HARDWARE. REVISION WITH HOFFMANN LRF EXTERNAL FIXATION.

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

  MAUDE report 12333014 ↗
• InjuryDec 12, 2020Fracture; Fracture

  THE CUSTOMER REPORTED THAT THE GAMMA 3 FEMORAL NAIL (RIGHT) BROKE AT PROXIMAL END IN-SITU, JUST ABOVE LAG SCREW HOLE. THE NAIL HAS SUBSEQUENTLY SUNK AND CAUSED THE DISTAL LOCKING SCREWS TO SNAP. THIS NAIL HAS BEEN SUCCESSFULLY EXTRACTED AND REVISED.

  Patient problems: Failure of Implant; Fall; Implant Pain

  MAUDE report 10996966 ↗
• InjuryDec 12, 2020Fracture; Fracture

  THE CUSTOMER REPORTED THAT THE GAMMA 3 FEMORAL NAIL (RIGHT) BROKE AT PROXIMAL END IN-SITU, JUST ABOVE LAG SCREW HOLE. THE NAIL HAS SUBSEQUENTLY SUNK AND CAUSED THE DISTAL LOCKING SCREWS TO SNAP. THIS NAIL HAS BEEN SUCCESSFULLY EXTRACTED AND REVISED.

  Patient problems: Failure of Implant; Fall; Implant Pain

  MAUDE report 10996720 ↗
• MalfunctionSep 23, 2020Fracture; Fracture

  SCREW BROKE AFTER BEING IMPLANTED IN THE PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 10573295 ↗
• InjuryJul 31, 2020Fracture; Fracture

  THE CUSTOMER REPORTED THAT THE GAMMA NAIL BROKE REQUIRING REVISION. LOCKING SCREWS ALSO BROKE. INITIAL IMPLANT IN (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 10350340 ↗
• InjuryMar 10, 2020Fracture; Fracture

  THE CUSTOMER REPORTS A BREAKAGE OF THE NAIL. X-RAYS SHOWED THAT THE LOCKING SCREWS WERE ALSO BROKEN. A REVISION SURGERY WAS PERFORMED.

  Patient problems: Failure of Implant; Injury

  MAUDE report 9813233 ↗
• MalfunctionNov 27, 2019Fracture; Fracture

  THE SURGEON REPORTED THAT HE WAS UNDERTAKING A FEMORAL NAIL (T2 GTN) PROCEDURE. A NON-STRYKER NAIL WAS BEING REVISED AND THERE WAS A GAP IN THE FRACTURE SITE. THE SURGEON UNDERTOOK A 'SLAPPING BACK' PROCEDURE IN WHICH HE INSERTED THE DISTAL SCREWS THROUGH THE NAIL AND THEN SLAPPED THE NAIL THROUGH THE FRACTURE SITE TO REDUCE THE FRACTURE. THE PROXIMAL LOCKING SCREWS WERE INSERTED WITHOUT ISSUE. THE SURGEON THEN NOTICED ON THE FINAL DISTAL X-RAY THAT ONE OF THE SCREWS HAD SNAPPED, WHICH THE SURGEON ATTRIBUTED TO THE 'PROCESS', RATHER THAN THE SCREW QUALITY. THE SURGEON REMOVED HALF OF THE SCREW AND INSERTED ANOTHER OVER THE TOP. THERE WAS A 5-MINUTE DELAY WHILE HE REMOVED THE SCREW AND REPLACED IT. THERE WERE NO OTHER ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONALLY REPORTED: CONFIRMATION RECEIVED THAT HALF OF THE SCREW WAS LEFT IN THE PATIENT. INDICATION FOR IMPLANT USAGE: 3.2.A NON UNION.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9387508 ↗
• InjuryFeb 27, 2019Break; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2015, T2GTN WAS IMPLANTED IN THE LEFT FEMUR. THE NAIL WAS REVISED TO T2F AT (B)(6) 2019, BECAUSE THE NAIL WAS FRACTURED AFTER DEPLOYED IT AND THE PATIENT HAD BONE METASTASIS. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE TWO SCREWS AT DISTAL PART WERE BROKEN NAIL WAS NOT BROKEN.

  Patient problems: No Code Available

  MAUDE report 8374918 ↗
• InjuryOct 26, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT TIBIA WAS REVISED DUE TO SUSPICION OF INFECTION AFTER PATIENT PRESENTED WITH PUS AT THE IMPLANT SITE. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Unspecified Infection

  MAUDE report 8010648 ↗
• InjuryOct 26, 2018Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT'S RIGHT TIBIA WAS REVISED DUE TO SUSPICION OF INFECTION AFTER PATIENT PRESENTED WITH PUS AT THE IMPLANT SITE. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Unspecified Infection

  MAUDE report 8010647 ↗
• InjuryAug 21, 2018Migration or Expulsion of Device

  THE CUSTOMER REPORTED THAT A PROXIMAL T2 5MM LOCKING SCREW IMPLANTED ON (B)(6) 2018 BACKED OUT AFTER IMPLANTATION.

  Patient problems: No Code Available

  MAUDE report 7803363 ↗