MAUDE Adverse Event Report: STRYKER GMBH DISTAL ANTEROLATERAL TIBIA PLATE AXSOS 3 FOR RIGHT TIBIA 14 HOLE / L229MM; PLATE, FIXATION, BONE

Catalog Number	627494S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "patient who underwent orif for a tibial fracture on (b)(6) 2025.The patient experienced pain.X-ray examination confirmed fracture of the plate.The revision surgery is scheduled for (b)(6) 2025.".
Additional Manufacturer Narrative
Once the investigation has been 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 received plate was found to be broken around middle at the level of 6th round hole from the oblong hole.The nature of breakage exhibits typical characteristics of a fatigue failure with significant plastic deformation majorly along the edges and mostly on the instantaneous fracture zone.Fatigue fracture can be clearly distinguished with the presence of lines of rest, traversing from the lateral side towards the medial.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.A few x-rays that were provided were presented to our hcp who opined that it is clearly a very complex high energy trauma, where the body did try to get the fracture to heal.But unfortunately for the patient the healing was not fast enough.It is a case of a hypertrophic non-union of the proximal part of the fracture, this contributed to the failure of the implant.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 implant.The ifu clearly instructs the user that: the implant is intended for temporary bone fixation.In the event of a delay in bone consolidation, or if such consolidation does not take place, or if explantation is not carried out, complications may occur, for example fracture or loosening of the implant or instability of the implant system.The surgeon must warn patient that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity, trauma, mal-union or nonunion and that the device has a finite expected service life and may need to be removed at some time in the future.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "patient who underwent orif for a tibial fracture on (b)(6) 2025.The patient experienced pain.X-ray examination confirmed fracture of the plate.The revision surgery is scheduled for (b)(6) 2025.".

• Brand Name: DISTAL ANTEROLATERAL TIBIA PLATE AXSOS 3 FOR RIGHT TIBIA 14 HOLE / L229MM
• 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: 23988982
• Report Number: 0008031020-2026-00010
• Device Sequence Number: 19971937
• Product Code: HRS
• UDI-Device Identifier: 07613327082111
• UDI-Public: (01)07613327082111(17)290430(10)AF5717
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 04/13/2026

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: 627494S
• Device Lot Number: AF5717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2024
• 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: 40 YR
• Patient Sex: Male