NA 1896-5042SRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04546540382344), received between Jul 23, 2018 and Jul 8, 2026 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2026Fracture

  THE PATIENT SENT A LETTER TO STRYKER WITH THE FOLLOWING CONTENT: "ON (B)(6) 2026, SEVERAL OF YOUR IMPLANTS WERE IMPLANTED AT (B)(6). ON (B)(6) 2026, THE LOWER SCREWS WERE STILL INTACT. ON (B)(6) 2026, THE UPPER SCREW HAD SNAPPED CLEAN THROUGH.

  Patient problems: Insufficient Information

  MAUDE report 25750372 ↗
• 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) 2025. NAIL HAS A BROKEN LAG SCREW HOLE SECTION, AND TWO LOCKING SCREWS WERE ALSO BROKEN.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 22444967 ↗
• InjuryMar 12, 2025Biocompatibility; Biocompatibility

  AS PER THE LEGAL DEPARTMENT'' BGHM (BERUFSGENOSSENSCHAFT HOLZ UND METALL) INSURANCE HAVE REPORTED THAT THERE IS AN INCREASE IN LEAD, CHROMIUM, COBALT, ZINC AND CADMIUM HAS BEEN DETECTED IN THEIR INSURED¿S BLOOD AND URINE. AN ALLEGATION HAS BEEN MADE BY THE INSURED PATIENT¿S TREATING PHYSICIAN THAT THIS COMPLAINT MAY BE DUE TO THE T2 FEMORAL NAIL IMPLANTED IN THE PATIENT IN (B)(6) 2007."

  Patient problems: Metal Related Pathology

  MAUDE report 21587921 ↗
• InjuryMar 12, 2025Biocompatibility; Biocompatibility

  AS PER THE LEGAL DEPARTMENT'' BGHM (BERUFSGENOSSENSCHAFT HOLZ UND METALL) INSURANCE HAVE REPORTED THAT THERE IS AN INCREASE IN LEAD, CHROMIUM, COBALT, ZINC AND CADMIUM HAS BEEN DETECTED IN THEIR INSURED¿S BLOOD AND URINE. AN ALLEGATION HAS BEEN MADE BY THE INSURED PATIENT¿S TREATING PHYSICIAN THAT THIS COMPLAINT MAY BE DUE TO THE T2 FEMORAL NAIL IMPLANTED IN THE PATIENT IN 2007."

  Patient problems: Metal Related Pathology

  MAUDE report 21587919 ↗
• InjuryMar 10, 2025Migration; Migration

  IT WAS REPORTED BY THE PATIENTS ATTORNEY THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO BACKING OUT OF THE SCREW WHICH PROTRUDED FROM THE SKIN. THE ATTORNEY WANTED TO KNOW IF THIS PRODUCT WAS RECALLED.

  Patient problems: Perforation

  MAUDE report 21559243 ↗
• InjurySep 13, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "(B)(6). 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 17738091 ↗
• InjuryJun 19, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "SPONTANEOUS FRACTURE OF THE IMPLANTED GAMMA NAIL WITHOUT TRAUMA APPROXIMATELY 8 MONTHS AFTER IMPLANTATION." UPON RECEIPT OF THE RETURNED PRODUCTS THE LOCKING SCREW WAS ALSO FOUND TO BE BROKEN.

  Patient problems: Failure of Implant

  MAUDE report 17159507 ↗
• 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) OSPITAL, (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 VAR

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

  MAUDE report 14610043 ↗
• MalfunctionOct 20, 2020Material Fragmentation; Material Twisted/Bent; Material Fragmentation; Material Twisted/Bent

  AS REPORTED: NO TRAUMATIC EVENT WAS EXPERIENCED. DEVICE HAS NOT BEEN REMOVED OR REPLACED. ADDITIONALLY REPORTED ON 2-SEP-2020: "THE IMPLANT I WAS INFORMED HAS FAILED WITHOUT ANY SUPPOSED TRAUMATIC EVENT TO THE SURGERY POST PROCEDURE." "THE DEVICE IS SCHEDULED TO BE REMOVED TODAY." "THE NAIL HAS BEEN REMOVED AND THERE IS AN APPARENT CRACK IN THE PROXIMAL END OF THE NAIL WITH ONE OF THE SCREWS BROKEN" UPON RECEIPT OF PRODUCT, 2 OTHER SCREWS WERE FOUND BENT AND HIGHLY WORN (PORTIONS OF THREADS DETACHED/MISSING).

  Patient problems: Failure of Implant

  MAUDE report 10708162 ↗
• MalfunctionOct 20, 2020Material Fragmentation; Material Twisted/Bent; Material Fragmentation; Material Twisted/Bent

  AS REPORTED: NO TRAUMATIC EVENT WAS EXPERIENCED. DEVICE HAS NOT BEEN REMOVED OR REPLACED. ADDITIONALLY REPORTED 2-SEP-2020: "THE IMPLANT I WAS INFORMED HAS FAILED WITHOUT ANY SUPPOSED TRAUMATIC EVENT TO THE SURGERY POST PROCEDURE." "THE DEVICE IS SCHEDULED TO BE REMOVED TODAY." "THE NAIL HAS BEEN REMOVED AND THERE IS AN APPARENT CRACK IN THE PROXIMAL END OF THE NAIL WITH ONE OF THE SCREWS BROKEN." UPON RECEIPT OF PRODUCT, 2 OTHER SCREWS WERE FOUND BENT AND HIGHLY WORN (PORTIONS OF THREADS DETACHED/MISSING).

  Patient problems: Failure of Implant

  MAUDE report 10708156 ↗
• InjuryJul 12, 2019Break; Fracture; Appropriate Device Problem Term/Code Not Available

  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: No Information

  MAUDE report 8784559 ↗
• InjuryOct 18, 2018Insufficient Device Problem Information

  FOR 1 WEEK WITHOUT RECURRENT TRAUMA, INCREASED PAIN ON THE HIP, LEFT SIDE, AFTER, ON (B)(6) 2018 WITH GAMMA NAIL OSTEOSYNTHESIS TREATED, PERTROCHANTERIC FEMUR FRACTURE, LEFT SIDE, WITH UNCOMPLICATED POSTOPERATIVE COURSE AND RADIOLOGICALLY CONTROLLED, PROPER IMPLANT POSITION.

  Patient problems: Pain

  MAUDE report 7982160 ↗
• InjuryJul 23, 2018Break

  THE MANUFACTURER BECAME AWARE OF A POST MARKET CLINICAL FOLLOW-UP (PMCF) FROM (B)(6) UNIVERSITY HOSPITAL (B)(6). THE TITLE OF THIS REPORT IS ¿ANALYSIS OF THE T2 RECON NAIL USED WITH THE ANTEGRADE LOCKING MODE¿ WHICH WAS RELEASED IN JUNE 2018 AND IS ASSOCIATED WITH THE T2 RECON NAILING SYSTEM. WITHIN THAT REPORT, POSTOPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN JANUARY 2014 AND NOVEMBER 2017. BASED ON THE AVAILABLE DEVICE AND PATIENT INFORMATION AND A REVIEW OF COMPLAINT HANDLING DATABASE IT WAS REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE REPORT, THEREFORE 15 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE JOURNAL. THIS PRODUCT INQUIRY ADDRESSES SEPTIC NONUNION DISCOVERED FROM THE EVENT OF CASE (B)(4). ONE OUT OF 1 CASE. THE PMCFR STATES: ¿IN THE SECOND CASE (CASE (B)(4)) IT WAS A TRANSVERSE FRACTURE (32-A) IN A HEAVY (B)(6) LADY. SHE IS (B)(6). THE BREAKAGE OF ALL THREE LOCKING SCREWS WAS OBSERVED. IN FACT A SEPTIC NONUNION WAS OBSERVED AND A REVISION SURGERY WAS PERFORMED 142 DAYS AFTER THE INITIAL SURGERY. ALL THE BROKEN SCREWS WERE REMOVED (18965050S-K05D869;18965

  Patient problems: Nonunion/Delayed-union Bone Fracture; Sepsis

  MAUDE report 7710756 ↗
• InjuryJul 23, 2018Break

  THE MANUFACTURER BECAME AWARE OF A POST MARKET CLINICAL FOLLOW-UP (PMCF) FROM (B)(6) UNIVERSITY HOSPITAL (B)(6). THE TITLE OF THIS REPORT IS ¿ANALYSIS OF THE T2 RECON NAIL USED WITH THE ANTEGRADE LOCKING MODE¿ WHICH WAS RELEASED IN JUNE 2018 AND IS ASSOCIATED WITH THE T2 RECON NAILING SYSTEM. WITHIN THAT REPORT, POSTOPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN JANUARY 2014 AND NOVEMBER 2017. BASED ON THE AVAILABLE DEVICE AND PATIENT INFORMATION AND A REVIEW OF COMPLAINT HANDLING DATABASE IT WAS REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE REPORT, THEREFORE 15 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE JOURNAL. THIS PRODUCT INQUIRY ADDRESSES IMPLANT BREAKAGE. 2 (CASE (B)(4)) OUT OF 3 CASES. THE PMCFR STATES: ¿IN 3 CASES (CASE (B)(4)) BREAKAGE OF THE MATERIAL OCCURRED. THE BREAKAGE WAS SITUATED ON THE LOCKING SCREWS AND NEVER ON THE NAIL ITSELF. IN THE SECOND CASE (CASE (B)(4)) IT WAS A TRANSVERSE FRACTURE (32-A) IN A HEAVY (B)(6) LADY. SHE IS (B)(6). THE BREAKAGE OF ALL THREE LOCKING SCREWS WAS OBSERVED. IN FACT A SEPTIC NONUNION WAS OBSERVED AND A REVISION SURGER

  Patient problems: No Code Available

  MAUDE report 7710517 ↗