NA 1896-5045SRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04546540202505), received between Jul 20, 2018 and Oct 29, 2025 — classified as 17 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (14 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2025Positioning Failure; Positioning Failure

  AS REPORTED: "THE MOST PROXIMAL SCREW WAS UNABLE TO PASS THROUGH THE NAIL AND BECAME STUCK. THIS SCREW WAS NOT INSERTED, LEAVING THE BONE TUNNEL OPEN.".

  Patient problems: Perforation

  MAUDE report 23418100 ↗
• InjurySep 3, 2025Biocompatibility; Biocompatibility

  CUSTOMER SERVICE WAS CONTACTED BY A PATIENT INFORMING SHE HAS BEEN SUFFERING FROM SEVERE SKIN RASHES AND PAIN AFTER AN IMPLANT EMERGENCY SURGERY IN THE UPPER ARM AND REQUESTS SAMPLE OF THE COMPOSITION (METALS ETC) OF THE IMPLANTS AND SCREWS AS WELL AS A SAMPLE OF THE IMPLANTS SO THAT THE LAB/DERMATOLOGIST CAN DETERMINE WHETHER THE PARTS NEED TO BE REMOVED OR WHETHER THERE IS ANOTHER SOLUTION.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 22950343 ↗
• 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: (B)(6) 2022: DISPLACEMENT OF THE DISTAL LOCKING SCREWS DURING MARKET RESUMPTION (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 (B)(6) 2024: INCOMPLETE BREAKAGE OF THE PROXIMAL PART OF THE GAMMA LONG NAIL AND SCHEDULING OF A REOPERATION FOR NAIL EXTRACTION. (B)(6) 2025: NAIL EXTRACTION."

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

  MAUDE report 22803498 ↗
• InjuryMar 5, 2025Break; Fracture; Migration; Break; Fracture; Migration

  BROKEN LONG GAMMA NAIL. ADDITIONAL INFORMATION RECEIVED: PATIENT UNDERWENT REVISION SURGERY (B)(6) 2024, EXCHANGED BROKEN NAIL WITH SMITH & NEPHEW 13X400MM INTERTAN NAIL. UPDATED INFORMATION: DURING THE REVIEW OF THE X-RAYS THE SCREW THAT WAS FOUND TO BE BROKEN DURING THE INVESTIGATION, WAS MIGRATED 6 WEEKS POST-OPERATIVE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21531745 ↗
• InjuryMay 17, 2024Break; Fracture; Break; Fracture

  AS REPORTED: THE PATIENT'S ATTORNEY CONTACTED STRYKER WITH THE FOLLOWING ISSUE: THE PATIENT WAS OPERATED ON AT THE BEGINNING OF (B)(6) 2023 FOR A FRACTURE OF THE FEMORAL NECK AND A GAMMA NAIL WAS INSERTED. ON (B)(6) 2023, THE GAMMA NAIL BROKE IN THE AREA OF THE RIGHT THIGH. THE PATIENT SUBSEQUENTLY HAD AN INPATIENT STAY FROM (B)(6) 2023. 04.22.2024 - UPDATE: "ADDITIONALLY A BROKEN LOCKING SCREW WAS REPORTED."

  Patient problems: Failure of Implant

  MAUDE report 19341456 ↗
• InjuryFeb 1, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PATIENT HAD BROKEN HER SUBTROCHANTER WHILST SKIING. IN AUSTRIA SHE GOT AN TFNA. THE TFNA WAS BROKEN AND REPLACED BY A GAMMA3 ON (B)(6) 2023. ALSO THIS GAMMA3 BROKE, AT THE LAG SCREW AND LOCKING SCREW ON (B)(6) 2023. REVISION WAS ON (B)(6) 2023. THE PATIENT FELT THE NAIL BREAKING AND HAD ACUTE PAIN. SHE WAS WALKING IN A STORE WHEN IT HAPPENED. THE GAMMA WAS REMOVED. THERE WAS 2 CM BONE REMOVED AT THE FRACTURE SITE AND REPLACED BY A T2ALPHA RECON NAIL. ALSO THE GAP WAS FILLED WITH BONE CEMENT. (CEREMENT). IT WAS CONFIRMED ON RECEIPT OF THE DEVICES THAT ONE OF THE LOCKING SCREWS WAS ALSO BROKEN.

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

  MAUDE report 18623706 ↗
• InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "I TAKE CARE OF A PATIENT AFTER OSTEOSYNTHESIS OF THE RIGHT FEMUR. THE OPERATION WAS CARRIED OUT IN (B)(6) 2019. THE PATIENT CAME TO OUR DEPARTMENT FOR FEMORAL HEAD NECROSIS WITH OSTEOMYELITIS AND SOFT TISSUE ABSCESS OF THE THIGH. WE NEED TO EXTRACT THE IMPLANTS. THIS IS A STRYKER 3 GAMMA NAIL SYSTEM. THE OPERATION IS SCHEDULED FOR (B)(6) 2022."

  Patient problems: Abscess; Necrosis; Osteomyelitis

  MAUDE report 16496489 ↗
• InjuryJan 25, 2023Break; Fracture; Break; Fracture

  PATIENT EXPERIENCED PAIN AND LAMENESS WHEN WALKING, WHICH REQUIRED REVISION SURGERY. THERE WAS A DELAY IN CONSOLIDATION, PSEUDARTHROSIS BUT EVEN IN THESE CONDITIONS IT IS ONLY 5 MONTHS SINCE PLACEMENT SO IN MY OPINION THE NAIL SHOULD HOLD MORE THAN THAT. UPON PRODUCT RETURN, TWO LOCKING SCREWS WERE FOUND BROKEN.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Implant Pain; Nonunion/Delayed-union Bone Fracture

  MAUDE report 16239837 ↗
• InjuryJan 25, 2023Break; Fracture; Break; Fracture

  PATIENT EXPERIENCED PAIN AND LAMENESS WHEN WALKING, WHICH REQUIRED REVISION SURGERY. THERE WAS A DELAY IN CONSOLIDATION, PSEUDARTHROSIS BUT EVEN IN THESE CONDITIONS IT IS ONLY 5 MONTHS SINCE PLACEMENT SO IN MY OPINION THE NAIL SHOULD HOLD MORE THAN THAT. UPON PRODUCT RETURN, TWO LOCKING SCREWS WERE FOUND BROKEN.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Implant Pain; Nonunion/Delayed-union Bone Fracture

  MAUDE report 16239832 ↗
• InjuryOct 17, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT AN UPCOMING REVISION SURGERY OF A BROKEN IMPLANT (GAMMA3 NAIL) IS SCHEDULED. UPON PRODUCT RETURN, ONE OF THE LOCKING SCREW WAS ALSO FOUND TO BE BROKEN.

  Patient problems: Failure of Implant

  MAUDE report 15616131 ↗
• InjuryApr 20, 2022Break; Fracture; Break; Fracture

  A GAMMA NAIL BROKE AT LAG SCREW HOLE 4 MONTHS POST-OP. DURING THE INSPECTION ONE OF THE RETURNED LOCKING SCREWS WAS FOUND BROKEN DUE TO FATIGUE.

  Patient problems: Failure of Implant

  MAUDE report 14163587 ↗
• InjuryJan 20, 2022Break; Fracture; Break; Fracture

  CUSTOMER REPORTED A BROKEN GAMMA NAIL 3 TITANIUM. ON THE (B)(6) 2021 THE BROKEN GAMMA NAIL WAS REMOVED AND A PSEUDARTHROSIS TREATMENT WAS PERFORMED (TISSUE SAMPLING, CLEANING OF FRACTURE SITE, RE-OSTEOSYNTHESIS WITH A PROXIMAL FEMORAL PLATE ON THE LATERAL SIDE AND AN AO SMALL FRAGMENT PLATE ON THE VENTRAL SIDE WITH SPONGIOSA/FILLING WITH BONE- CHIPS). A BROKEN SCREW WAS ALSO REPORTED.

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

  MAUDE report 13303789 ↗
• 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 13156211 ↗
• MalfunctionOct 30, 2021Difficult to Remove; Mechanical Jam; Difficult to Remove; Mechanical Jam

  THE CUSTOMER REPORTED THE FOLLOWING: UPON ATTEMPTING EXPLANTATION, ONE OF THE DISTAL LOCKING PINS WAS FOUND TO BE COLD WELDED. THE BOLT HAD TO BE EXPOSED VENTRALLY AND DORSALLY AND MILLED OFF SO THAT THE NAIL COULD BE KNOCKED OUT OF THE MEDULLARY CANAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12724905 ↗
• InjuryOct 21, 2021Fracture; Fracture

  IT WAS REPORTED A PATIENT WITH NORMAL WEIGHT SHOWED FRACTURE OF THE GAMMA NAIL FOUR WEEKS AFTER IMPLANTATION. IN THE FURTHER COURSE, THE LOCKING SCREW ALSO BROKE, EVEN IF THE SCREW IN THIS CASE IS TO BE CONSIDERED TOO SHORT. THE PATIENT REQUIRED A REVISION SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 12676981 ↗
• MalfunctionSep 21, 2021Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT: "I AM CONTACTING YOU REGARDING A DISPUTE THAT HAS ARISEN IN THE ORTHOPAEDIC SURGERY ON A LOCKING SCREW REFERENCE 18965045S (LOT: K09FE39 - IMPLANTATION DEADLINE: (B)(6) 2025). THE SURGEON REPORTED THAT THE LOCKING SCREW THREAD FRAYED INTO THE NAIL DURING INSERTION AND REMOVAL, RESULTING IN EXTRACTION DIFFICULTIES AND THE CREATION OF INTRAMEDULLARY DEBRIS." ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER - 09/06/2021: "THE OPERATION WAS COMPLETED CORRECTLY WITH A LONGER OPERATION TIME OF BETWEEN 15 AND 30 MINUTES AND THE NEED FOR A LARGER APPROACH DUE TO THE NEED TO REMOVE THE MORE DIFFICULT MATERIAL."

  Patient problems: Foreign Body In Patient

  MAUDE report 12505288 ↗
• InjuryAug 18, 2020Fracture; Fracture

  THE CUSTOMER REPORTED A BROKEN GAMMA NAIL WHICH IS IN NEED OF REVISION. REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2020. ADDITIONALLY REPORTED: THE SURGEON COMMENTED THAT THE PATIENT WAS A SMOKER AND OTHER PATIENT FACTORS HAD LED TO DELAYED UNION AND THAT¿S WHY HE FELT IMPLANT HAD BROKEN. LOCKING SCREW WAS ALSO BROKEN.

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

  MAUDE report 10423193 ↗
• 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 9813235 ↗
• MalfunctionDec 19, 2019Fracture; Difficult to Advance; Fracture; Difficult to Advance

  IT WAS REPORTED: THE SCREW DID NOT ADVANCE DURING T2 PROXIMAL LATERAL LOCKING. WHEN TRYING TO PUSH IN, THE SCREW BROKE. AN ALTERNATIVE SCREW WAS USED. THE BROKEN PART WAS REMOVED. THE PATIENT WAS NOT DAMAGED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9492815 ↗
• 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 8374916 ↗
• InjuryJul 20, 2018Device Dislodged or Dislocated

  THE CUSTOMER REPORTED THAT 2 X PROXIMAL T2 5 MM LOCKING SCREWS IMPLANTED ON (B)(6) 2018 BACKED OUT THE PATIENT WILL HAVE THE SCREW RE INSERTED DURING AN UPCOMING SPINAL SURGERY WHILE HE¿S ASLEEP.

  Patient problems: Failure of Implant

  MAUDE report 7707349 ↗