MAUDE Adverse Event Report: Stryker GmbH AXSOS 3 DISTAL LATERAL FEMUR PLATE FOR RIGHT FEMUR 8 HOLE / L202MM; Plate, Fixation, Bone

Catalog Number	627638S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a plate failure that resulted in the metalwork being explanted.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that there was a plate failure that resulted in the metalwork being explanted.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Routine post market surveillance trending activities are performed in accordance with the regulation to monitor post-market data and identify potential trends or threshold exceedances.Based on the available data, no recurring situation for axsos plate postoperative breakages has been identified.The latest periodic safety update report (psur)/complaint analysis covering shows that the occurrence rate for postoperative implant breakage remains well below the acceptable rate defined in the risk management file.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: AXSOS 3 DISTAL LATERAL FEMUR PLATE FOR RIGHT FEMUR 8 HOLE / L202MM
• Common Device Name: Plate, Fixation, Bone
• Manufacturer (Section D): Stryker GmbH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): Stryker GmbH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 25689518
• Report Number: 0008031020-2026-00803
• Device Sequence Number: 15870425
• Product Code: HRS
• UDI-Device Identifier: 04546540685742
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 627638S
• Device Lot Number: AD0201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2026
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 07/02/2026
• Supplement Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown