MAUDE Adverse Event Report: STRYKER GMBH T2 ALPHA FEMUR ANTEGRADE - FEMORAL NAIL GT, RIGHT D12X360MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23331236S
Medical Device Problem Codes	Malposition of Device (2616); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the lag screw of the t2alphagt was not seated within the screw hole, resulting in femoral shortening when the patient applied weight postoperatively, causing the proximal end of the nail to protrude from the femur.".
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "the lag screw of the t2alphagt was not seated within the screw hole, resulting in femoral shortening when the patient applied weight postoperatively, causing the proximal end of the nail to protrude from the femur.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the provided x rays clearly shows the implant protruding out of femur.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.Hcp opinion was taken on the provided x rays which concluded that the event likely occurred due to improper seating positioning of the lag screws.Femoral shortening and subsequent proximal nail protrusion could occur if both lag screws were positioned adjacent to the nail rather than properly seated within the intended screw holes.It was further noted that the procedure may not have been performed correctly and that verification of k wire, drill, and lag screw positioning using sufficient fluoroscopic views should have been performed prior to completion of the procedure.The hcp additionally commented that the postoperative radiographs demonstrate lag screws in a different orientation compared with the distal screws, and the apparent divergence non parallel orientation of the lag screws should have been recognized intraoperatively, as the screws are generally expected to follow a consistent trajectory.Based on the hcp remarks and currently available postoperative radiographic findings, the event appears potentially associated with lag screw positioning and or engagement related factors, which may have contributed to construct instability and subsequent femoral shortening with nail protrusion under postoperative loading.However, the available postoperative radiographs alone do not allow definitive confirmation of the exact root cause, and further correlation with intraoperative imaging, procedural details, and additional device assessment would be required for conclusive determination.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: T2 ALPHA FEMUR ANTEGRADE - FEMORAL NAIL GT, RIGHT D12X360MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA GMBH; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24670489
• Report Number: 0008031020-2026-00454
• Device Sequence Number: 14716353
• Product Code: HSB
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 23331236S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown