MAUDE Adverse Event Report: STRYKER GMBH AXSOS 3 CORTEX SCREW D3.5MM / L24MM; PLATE, FIXATION, BONE

Catalog Number	661424
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "a revision surgery had to be performed using synthes.The patient had to have another surgery.The plate failed according to surgeon and a locking screw pulled through the pangea distal humerus plate.
Event or Problem Description
As reported: "a revision surgery had to be performed using synthes.The patient had to have another surgery.The plate failed according to surgeon and a locking screw pulled through the pangea distal humerus plate.
Additional Manufacturer Narrative
The reported event was confirmed during the investigation.The device inspection revealed the following: the identification of the returned screw was confirmed based on the catalog number and catalog number marked.The returned bone screw is fractured below the head, which was the only part returned.The lines of rest visible on the breakage surface indicate a fatigue fracture caused by continuous excessive loading, as confirmed by the presence of rest lines.It should be noted that more detailed information about the event, as well as x-ray images, would have been necessary to conduct a complete investigation.The exact root cause of the incident could not be determined.During the device inspection, it was not possible to confirm any user-related error.However, this cannot be ruled out.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required currently.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design-related problems were found during the investigation.If more information is provided, the case will be reassessed.

• Brand Name: AXSOS 3 CORTEX SCREW D3.5MM / L24MM
• 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: 24495335
• Report Number: 0008031020-2026-00280
• Device Sequence Number: 4980167
• Product Code: HRS
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

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: 661424
• Device Lot Number: AL0073
• Date Returned to Manufacturer: 02/02/2026
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2024
• 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: 41 YR
• Patient Sex: Male