GAMMA 3425-1360SRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613252273837), received between Jun 10, 2019 and Aug 14, 2025 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 22803492 ↗
• InjuryJul 10, 2025Break; Fracture; Break; Fracture

  AS PER REPORTED BY THE CUSTOMER: "ALMOST NINE MONTHS AFTER IMPLANTATION OF THE NAIL TOGETHER WITH A CERCLAGE, A NAIL FRACTURE OCCURRED WITHOUT DIRECTLY ASSOCIATED TRAUMA (RECENT FALLS BETWEEN (B)(6) 2024 AND (B)(6) 2025 NOT EXCLUDED). RE-OPERATION WITH CHANGE TO HEAD PROSTHESIS WITH TROCHANTERIC SUPPORT PLATE. ALSO ALL RISKS ASSOCIATED WITH RE-OPERATION."

  Patient problems: Fall

  MAUDE report 22473559 ↗
• MalfunctionMay 8, 2025Mechanical Jam; Mechanical Jam

  AS REPORTED: "IMPOSSIBLE TO REMOVE THE NAIL-HOLDER BOLT AND THEREFORE THE NAIL-HOLDER FROM THE NAIL. OBLIGED TO REMOVE THE NAIL MOUNTED ON THE NAIL HOLDER AND REPEAT THE OP WITH ANOTHER GAMMA3 ANCILLARY. CHANGE ANCILLARY AND IMPLANT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21985711 ↗
• InjuryAug 20, 2024Break; Fracture; Device Damaged by Another Device; Break; Fracture; Device Damaged by Another Device

  IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT WENT TO EMERGENCY ROOM WHERE A TRAUMATIC BREAKAGE OF THE RIGHT FEMUR INTRAMEDULLARY NAIL WAS FOUND ONCE THE X-RAYS WAS PERFORMED (THE SAME WAS NOT PRESENT IN THE X-RAYS PERFORMED ON (B)(6) 2024). IMPLANT DATE WAS (B)(6) 2023. ADDITIONAL MEDICAL PROCEDURE WAS REQUIRED.

  Patient problems: Failure of Implant

  MAUDE report 20001579 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, PERSISTENT PAIN WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Implant Pain

  MAUDE report 19938640 ↗
• InjuryFeb 15, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED BY AUSTRALIAN REGISTRAR THAT THERE HAD A BROKEN FEMORAL NAIL. ADDITIONAL INFORMATION RECEIVED 1/2/24: ISSUE NOTICED AFTER FOLLOW UP X-RAYS FRACTURE CLINIC. PATIENT REQUIRED REMOVAL OF BROKEN HARDWARE AND REVISION TO TOTAL HIP REPLACEMENT. RIGHT SIDE. REASON FOR REVISION: FRACTURE NON-UNION + IMPLANT BREAKAGE."

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

  MAUDE report 18713166 ↗
• InjurySep 13, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "Z.N. TREATMENT OF A SUBTROCHANTERIC FEMUR FRACTURE WITH A LONG GAMMA NAIL (11MM X 360MM X 125°; FEMORAL NECK SCREW 115MM). POSTOPERATIVE FOLLOW-UP WITH PARTIAL WEIGHT BEARING FOR 8 WEEKS. PRESENTATION VIA CENTRAL EMERGENCY DEPARTMENT AFTER FALL WITH PAIN IN THE HIP. RADIOLOGICALLY SHOWED FRACTURE OF BOTH DISTAL SCREWS AS WELL AS THE GAMMA NAIL IN THE AREA OF THE FEMORAL NECK SCREW. REVISION SURGERY WAS PERFORMED WITH REMOVAL OF THE FRACTURED GAMMA NAIL AND RE-OSTEOSYNTHESIS WITH A FEMORAL NAIL."

  Patient problems: Failure of Implant; Fall; Implant Pain

  MAUDE report 17738015 ↗
• InjuryAug 25, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT AN UPCOMING REVISION SURGERY OF A BROKEN IMPLANT (GAMMA3 NAIL) IS SCHEDULED.

  Patient problems: Failure of Implant

  MAUDE report 15298779 ↗
• InjuryJun 2, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "GAMMA NAIL IS BROKEN. THE PATIENT REQUIRED REVISION SURGERY." ADDITIONALLY THE PATIENT HAD SUDDEN EXERTIONAL PAIN ON THE MORNING OF (B)(6) 2022. THE PATIENT WAS REVISED TO A CEMENTLESS STEM AND BIPOLAR CUP.

  Patient problems: Failure of Implant; Implant Pain; Pain

  MAUDE report 14574968 ↗
• InjuryDec 29, 2021Break; Fracture; Break; Fracture

  "CLIENT REPORTED BROKEN GAMMA 3 NAIL AT 6 WEEKS POST OPERATIVE. REVISION SURGERY NEEDED TO REMOVE BROKEN NAIL AND REPLACE WITH OTHER IMPLANT"

  Patient problems: Failure of Implant

  MAUDE report 13114424 ↗
• MalfunctionOct 21, 2019Loose or Intermittent Connection; Failure to Advance; Physical Resistance/Sticking; Failure to Advance

  IT WAS REPORTED: "ONCE DOCTOR HAD LAG SCREW IN CORRECT POSITION ON THE FIRST NAIL, HE PUT IN THE SET SCREW BUT IT DID NOT ENGAGE INTO THE PROXIMAL PART OF NAIL. IT SPUN LOOSELY AND WOULD NOT ADVANCE FURTHER DISTALLY OR BACK OUT TO TRY AND RE-POSITION. THE SAME EXACT OUTCOME HAPPENED ON THE SECOND NAIL. THE SET SCREW ENTERED THE NAIL AND GOT STUCK. DOCTOR TRIED A COUPLE DIFFERENT SET SCREWDRIVERS TO TRY AND BACK IT OUT. BOTH NAILS RESULTED WITH STUCK SET SCREWS THAT DID NOT ENGAGE INTO THE LAG SCREWS. DELAY IN SURGERY: 20 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DOCTOR CONCLUDED TO LEAVE BOTH OF THE NAILS IN. NO ADDITIONAL SURGERY IS PLANNED. NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9216237 ↗
• InjuryJun 10, 2019Fracture; Break; Fracture

  (B)(6) 2018 AN ELONGATED GAMMA3 NAIL WAS PLACED IN A 72-YEAR-OLD FEMALE PATIENT VIA AN OPEN REPOSITION PROCEDURE. TEN DAYS AFTER SURGERY THE PATIENT COULD START CAREFULLY LOAD HER INJURED LEG AGAIN. SHE DIDN¿T USE CRUTCHES NOR ROLLATOR. (B)(6) 2019 A CONTROL X-RAY SHOWED THAT THE DISTAL LOCKING SCREW WAS BROKEN. DOCTOR DECIDED NOT TO DO ANYTHING ABOUT IT IN ORDER TO GET MORE COMPRESSION IN THE FRACTURE SITE. THE NAIL PROVIDED DYNAMIZATION. HARDLY ANY CALLUS FORMATION WAS VISIBLE. REPORTED UNDER SEPARATE PI. (B)(6) 2019 A CONTROL X-RAY SHOWED A SLIGHT ANGULATION OF THE HIP AND BEGINNING CALLUS FORMATION ON THE MEDIAL SIDE WERE THE TROCHANTER MINOR FRACTURE WAS. THE HIP WAS 100% WAIT BEARING. NO FURTHER PROBLEMS. (B)(6) 2019 A CONTROL X-RAY FOLLOW-UP WAS MADE AND SHOWED THAT THE PROXIMAL PART OF THE NAIL HAD BEEN BROKEN. PATIENT MENTIONED TO EXPERIENCE A NEW PAIN SINCE THE 4TH OF MAY. ONLY BY STANDING UP SHE FELT PAIN IN HER RIGHT HIP. SHE DIDN¿T FALL NOR JUMP NOR DID ANYTHING ELSE THAT COMPROMISED HER HEALTH AND RECOVERY. (B)(6) 2019 A NEW ELONGATED GAMMA 3 NAIL WAS PLACED.

  Patient problems: Pain

  MAUDE report 8684873 ↗