MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FEMUR PLATE AXSOS 3 FOR RIGHT FEMUR 10 HOLE / L238MM; PLATE, FIXATION, BONE

Catalog Number	627640
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
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 surgeon removed a 10 hole plate that had broken.It was replaced with a distal femur 14 hole plate.No additional information is available.

• Brand Name: DISTAL LATERAL FEMUR PLATE AXSOS 3 FOR RIGHT FEMUR 10 HOLE / L238MM
• 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: 23846011
• Report Number: 0008031020-2025-02191
• Device Sequence Number: 9959081
• Product Code: HRS
• UDI-Device Identifier: 07613252579663
• UDI-Public: 07613252579663
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K222381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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: 627640
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/18/2025
• 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 Age: 86 YR
• Patient Sex: Female
• Patient Weight: 68 KG