MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FEMUR PLATE AXSOS 3 FOR RIGHT FEMUR 16 HOLE / L343MM; PLATE, FIXATION, BONE

Catalog Number	627646S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported: axsos femur plate broke after fixation of femur fracture.Revision surgery needed after the plate broke.
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: the received plate was found to be broken at the level of 10th hole from the broader side.The fracture surface clearly indicates towards a fatigue fracture evident by lines of rest on one of the broken side, progressing downwards while the other end exhibiting instantaneous fracture zone.It is likely that the breakage happened at the level of the fracture site due to a possible non-union, however, without radiographs it cannot be confirmed.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on available information, the breakage of the plate can be attributed to a fatigue failure however the exact reasons to affect it could not be determined as other patient details like medical records were not available at the time of investigation.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The following information was reported: axsos femur plate broke after fixation of femur fracture.Revision surgery needed after the plate broke.

• Brand Name: DISTAL LATERAL FEMUR PLATE AXSOS 3 FOR RIGHT FEMUR 16 HOLE / L343MM
• 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: 23818020
• Report Number: 0008031020-2025-02161
• Device Sequence Number: 10006472
• Product Code: HRS
• UDI-Device Identifier: 04546540685780
• UDI-Public: (01)04546540685780(17)271031(10)K60648
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K222381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: 627646S
• Device Lot Number: K60648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2022
• 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: Female
• Patient Weight: 50 KG