MAUDE Adverse Event Report: STRYKER GMBH AXSOS 3 DISTAL LATERAL FEMUR PLATE FOR RIGHT FEMUR 12 HOLE / L274MM; PLATE, FIXATION, BONE

Catalog Number	627642
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.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 fracture of osteosynthesis plate in right femur that required removal and nail insertion.
Additional Manufacturer Narrative
Correction to d4(lot/serial no.) and d9(product available to stryker).The reported event could be confirmed based on the provided x-rays.It is worth noting the provided lot number was not valid and is therefore unknown.The provided x-rays were forwarded to medical affairs, with the following review: « there is just too little information given to provide a reasoning for the plate breakage to occur.However, there are something worth commenting indeed: - the bone is quite spiky still, which might indicate the plate was not in there very long.- there seems to be some callus on the proximal side, which might indicate the body did try something.- the construction might have contributed to the failure as well.- we cannot say if this is a delayed or non-union in any way.The location and pattern of the fracture, biology, and the technical aspects of the surgical procedure have contributed to the event.Furthermore, patient activity levels post-op may also have contributed to an inadequate load distribution and, therefore, the breakage of the implants.» 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.Based on the above investigation, the root cause was attributed to a combination of user and patient condition related issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that there was fracture of osteosynthesis plate in right femur that required removal and nail insertion.

• Brand Name: AXSOS 3 DISTAL LATERAL FEMUR PLATE FOR RIGHT FEMUR 12 HOLE / L274MM
• 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 ; 2018315000
• MDR Report Key: 23769155
• Report Number: 0008031020-2025-02137
• Device Sequence Number: 18795568
• Product Code: HRS
• UDI-Device Identifier: 07613252579670
• UDI-Public: 07613252579670
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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: 627642
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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