NA 1896-5040SRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04546540202499), received between Sep 16, 2016 and Jul 10, 2026 — classified as 18 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2026Fracture

  IT WAS REPORTED THAT A GAMMA3 NAIL WAS IMPLANTED ON (B)(6) 2025. WOUND REVISION TOOK PLACE IN (B)(6) 2026. ON (B)(6) 2026, A FRACTURE WAS DETECTED WITHOUT A FALL. REVISION TOOK PLACE ON (B)(6) 2026, FOLLOWED BY A HIP REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 25780516 ↗
• InjuryJun 30, 2026Fracture

  It was reported that, the surgery took place on (b)(6)2025. It was further reported, the fracture of a long Gamma3 nail in the area of the femoral neck screw, as well as fracture of a 5mm distal locking screw. No further information was provided.

  Patient problems: Insufficient Information

  MAUDE report 25667846 ↗
• InjuryMay 13, 2026Fracture

  AS REPORTED: "APPROXIMATELY 6 WEEKS AFTER IMPLANTATION, THE GAMMA3 NAIL BROKE. PATIENT REQUIRED REVISION SURGERY."

  Patient problems: Insufficient Information

  MAUDE report 25164945 ↗
• InjuryOct 15, 2025Fracture; 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." 09/16/2025 - UPON PRODUCT RETURN, ONE LOCKING SCREW WAS FOUND BROKEN.

  Patient problems: Fall

  MAUDE report 23300719 ↗
• InjurySep 30, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "FRACTURE OF THE GAMMA3 IMPLANT AND A LOCKING SCREW. REVISION OP- METAL REMOVAL OF THE GAMMA3 AND NEW HIP PROSTHESIS INSERTED ON (B)(6) 2025."

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

  MAUDE report 23185325 ↗
• InjuryNov 12, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "GAMMA NAIL IS BROKEN AT THE ENTRY POINT OF THE FEMORAL NECK SCREW. METAL REMOVAL NECESSARY." ON THE X-RAY ATTACHED IN THE INTAKE, WE SEE THAT ONE OF THE DISTAL LOCKING SCREW IS ALSO BROKEN.

  Patient problems: Failure of Implant

  MAUDE report 20665451 ↗
• InjuryMay 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AROUND THE IMPLANTS, AND SO THEY WERE REMOVED.

  Patient problems: Implant Pain

  MAUDE report 16973863 ↗
• InjuryJan 23, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "DURING X-RAY IN HOSPITAL AFTER PAIN OF PATIENT FRACTURE OF THE IMPLANT DETECTED ON (B)(6) 2022. ADDITIONALLY, UPON PRODUCT RETURN, ONE LOCKING SCREW WAS FOUND BROKEN."

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 16223249 ↗
• InjurySep 23, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THERE WAS A REVISION DUE TO A FRACTURE OF A GAMMA IMPLANT. ONE SCREW BROKE, AND NAIL DIDN'T BROKE.

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

  MAUDE report 15474438 ↗
• InjuryJun 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE ¿DEPARTMENT OF (B)(6) CENTER, (B)(6) HOSPITAL, (B)(6)¿. THE TITLE OF THIS REPORT IS, ¿EVALUATION OF INTRAMEDULLARY NAIL FIXATION VIA THE NEVIASER PORTAL FOR PROXIMAL HUMERUS FRACTURE¿ PUBLISHED ON FEBRUARY 08, 2019, WHICH IS ASSOCIATED WITH THE STRYKER ¿T2 PROXIMAL HUMERAL NAILING SYSTEM¿. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1016/J.JCOT.2019.02.007. THIS REPORT INCLUDES AN ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 4 PATIENTS. THE CASES IN THIS STUDY RANGE FROM APRIL 2014 AND MARCH 2017. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE. IT WAS REPORTED THAT 1 PATIENT EXPERIENCED PAIN, AND RESTRICTED RANGE OF MOTION (ROM) DUE TO FAILURE OF FIXATION WITH RECURRENT VARUS DEFORMITY AND SLIPPING OUT OF THE PROXIMAL INTERLOCKING SCREW. THE REPORT STATES, ¿IN THIS CASE, WE USED A BENT NAIL UNLIKE THE OTHER THREE CASES IN WHICH STRAIGHT NAILS WERE USED. WE CONSIDER THIS DIFFERENCE CAN BE A CAUSE OF THIS COMPLICATION. THIS PATIENT ALSO EXPERIENCED FAILURE OF FIXATION WITH RECURRENT V

  Patient problems: Deformity/ Disfigurement; Implant Pain; Loss of Range of Motion

  MAUDE report 14610050 ↗
• InjuryJun 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE ¿DEPARTMENT OF (B)(6)CENTER, (B)(6) HOSPITAL, (B)(6)¿. THE TITLE OF THIS REPORT IS, ¿EVALUATION OF INTRAMEDULLARY NAIL FIXATION VIA THE NEVIASER PORTAL FOR PROXIMAL HUMERUS FRACTURE¿ PUBLISHED ON FEBRUARY 08, 2019, WHICH IS ASSOCIATED WITH THE STRYKER ¿T2 PROXIMAL HUMERAL NAILING SYSTEM¿. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1016/J.JCOT.2019.02.007. THIS REPORT INCLUDES AN ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 4 PATIENTS. THE CASES IN THIS STUDY RANGE FROM APRIL 2014 AND MARCH 2017. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE. IT WAS REPORTED THAT 1 PATIENT EXPERIENCED PAIN, AND RESTRICTED RANGE OF MOTION (ROM) DUE TO FAILURE OF FIXATION WITH RECURRENT VARUS DEFORMITY AND SLIPPING OUT OF THE PROXIMAL INTERLOCKING SCREW. THE REPORT STATES, ¿IN THIS CASE, WE USED A BENT NAIL UNLIKE THE OTHER THREE CASES IN WHICH STRAIGHT NAILS WERE USED. WE CONSIDER THIS DIFFERENCE CAN BE A CAUSE OF THIS COMPLICATION. THIS PATIENT ALSO EXPERIENCED FAILURE OF FIXATION WITH RECURRENT VA

  Patient problems: Deformity/ Disfigurement; Implant Pain; Loss of Range of Motion

  MAUDE report 14610004 ↗
• InjuryJan 21, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "ON (B)(6) 2021 THE HOSPITAL IMPLANT A NAIL 11X360, 125° 33250360TI, IT HAS TO BE CHANGED TODAY BECAUSE IT WAS BROKEN." ADDITIONAL INFORMATION RECEIVED FROM SURGEON - 11/17/2021: MR. (B)(6) A (B)(6) PATIENT OF NORMAL WEIGHT ((B)(6) 180CM) BROKE HIS RIGHT FEMUR ON (B)(6) 2021 IN THE SENSE OF A MULTIFRAGMENTARY SUBTROCHANTERIC FRACTURE (AO 31 A3.3). THE FRACTURE WAS OPENLY REDUCED ON THE SAME DAY AND TREATED WITH A CERCLAGE AND A LONG G3 NAIL. POSTOPERATIVELY, THE PATIENT WAS MOBILIZED UP TO FULL WEIGHT BEARING. THE PATIENT COULD BE DISCHARGED QUICKLY. 9 WEEKS AFTER TREATMENT ON (B)(6) 2021, THE PATIENT, WHO HAD PREVIOUSLY BEEN SYMPTOM-FREE, SUDDENLY HAD SC DURING NORMAL WALKING, AND THE SUBSEQUENT IMAGING SHOWED A NAIL FRACTURE.

  Patient problems: Failure of Implant

  MAUDE report 13313828 ↗
• MalfunctionJan 27, 2021Fracture; Fracture

  AS REPORTED: "SURGEON INSERTED A 5.0 LOCKING SCREW ACTING AS A "BLOCKING SCREW." WHILE INSERTING THE SCN (SUPRACONDYLAR NAILING SYSTEM), THE NAIL BROKE THE BLOCKING SCREW IN HALF. THE SURGEON WAS ABLE TO REMOVE THE TOP HALF OF THE SCREW, BUT THE BOTTOM HALF WAS LEFT IN THE PATIENT PERMANENTLY. THE SCN WAS IMPLANTED AND THE REST OF THE CASE WAS COMPLETED SUCCESSFULLY."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11237993 ↗
• MalfunctionSep 23, 2020Fracture; Fracture

  SCREW BROKE AFTER BEING IMPLANTED IN THE PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 10573459 ↗
• MalfunctionFeb 24, 2020Material Fragmentation; Material Separation; Material Fragmentation; Material Separation

  CUSTOMER REPORTED THAT : "DURING THE REMOVAL OF THE TITANIUM NAIL INSTALLED ON (B)(6) 2019, A SPRING APPEARS NEXT TO THE TITANIUM SCREW CORRESPONDING TO THE THREAD THAT HAS COME LOOSE." ADDITIONALLY REPORTED: PROCEDURE COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES. DELAY : 5MIN, TIME TO DETERMINE WHERE THIS METAL PIECE CAME FROM NO OTHER MEDICAL INTERVENTION. SPRING CAME FROM LOCKING SCREW. REMOVAL OF THE NAIL : REMOVAL OF THE NAIL WITHIN THE CONSOLIDATION PERIOD (18YEAROLD PATIENT, NAIL INSTALLED ON (B)(6) 2018)

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9748377 ↗
• MalfunctionFeb 24, 2020Material Fragmentation; Material Separation; Material Fragmentation; Material Separation

  CUSTOMER REPORTED THAT : "DURING THE REMOVAL OF THE TITANIUM NAIL INSTALLED ON (B)(6) 2019, A SPRING APPEARS NEXT TO THE TITANIUM SCREW CORRESPONDING TO THE THREAD THAT HAS COME LOOSE." ADDITIONALLY REPORTED: PROCEDURE COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES. DELAY : 5MIN, TIME TO DETERMINE WHERE THIS METAL PIECE CAME FROM NO OTHER MEDICAL INTERVENTION. SPRING CAME FROM LOCKING SCREW. REMOVAL OF THE NAIL : REMOVAL OF THE NAIL WITHIN THE CONSOLIDATION PERIOD (18YEAROLD PATIENT, NAIL INSTALLED ON (B)(6) 2018).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9747210 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, ALLERGIC REACTION, SKIN REDNESS 10 WEEKS POST SURGERY.

  Patient problems: Irritation; Reaction

  MAUDE report 9522043 ↗
• InjuryJul 12, 2019Break

  IT WAS REPORTED THAT THE PATIENT'S LEFT FEMUR WAS REVISED DUE TO FEMORAL PERIPROSTHETIC FRACTURE, AND BREAKAGE OF THE NAIL AT THE FRACTURE SITE. PATIENT WAS REVISED TO COMPETITOR DEVICES.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 8784554 ↗
• MalfunctionJun 13, 2019Fracture; Break; Fracture

  ON (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. ON (B)(6) 2019 A CONTROL X-RAY SHOWED THAT THE DISTAL LOCKING SCREW WAS BROKEN. SURGEON 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8695307 ↗
• MalfunctionFeb 13, 2019Difficult to Remove; Inadequacy of Device Shape and/or Size; Positioning Problem

  THE SURGEON REPORTED THAT HE WAS UNDERTAKING A 2 STAGE REVISION OF KNEE AND DECIDED TO USE A GAMMA NAIL AS A SPACER. DURING THE CASE HE INSERTED THE NAIL AND WHEN HE INSERTED ONE OF THE SCREWS IT WAS THE WRONG SIZE. THE SCREW WAS NOT FULLY SEATED AND WHEN THE SURGEON TRIED TO REMOVE IT, IT COLD WELDED ITSELF ONTO THE NAIL. THE SURGEON LEFT E NAIL AND SCREW IN SITU. THE REPORTED EVENT RESULTED IN A 2 HOUR DELAY TO SURGERY AND THE SURGEON WAS CONCERNED ABOUT THE RISK OF INFECTION DUE TO THE LENGTH OF TIME THE PATIENT WAS ON THE TABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8337608 ↗
• 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 8010635 ↗
• 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 7803355 ↗
• InjuryAug 21, 2018Device Slipped

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

  Patient problems: No Information

  MAUDE report 7803310 ↗
• InjuryMar 28, 2017Fracture; Fracture

  IT WAS REPORTED THAT LEFT GAMMA NAIL (LONG) BROKE. IN ADDITION REVIEW OF X-RAYS AND OP-REPORTS REVEALED PROXIMAL OF DISTAL SCREW ALSO BROKEN.

  Patient problems: Failure of Implant

  MAUDE report 6439786 ↗
• MalfunctionSep 16, 2016Device Packaging Compromised; Device Contamination with Chemical or Other Material

  A WHITE FOREIGN BODY ( LIKE FOAM) IN A PACKAGE. DR. USED SPARE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5955526 ↗