MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL LATERAL HUMERUS PLATE AXSOS 3 FOR RIGHT HUMERUS 3 HOLE / L86MM; PLATE, FIXATION, BONE

Catalog Number	627233S
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "patient underwent orif for humeral fracture on august 20, 2025.Axsos ph implanted.The patient had to undergo revision surgery due to re-dislocation of the bony fragment of the greater tuberosity of the humerus due to malpositioning of the plate.".
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed since the affected device was not returned and no other evidence was shared for evaluation.A device inspection was not available since the affected device was not returned.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.More information as well as the affected device must be available in order to determine the exact root cause of the issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "patient underwent orif for humeral fracture on (b)(6) 2025.Axsos ph implanted.The patient had to undergo revision surgery due to re-dislocation of the bony fragment of the greater tuberosity of the humerus due to malpositioning of the plate.".

• Brand Name: PROXIMAL LATERAL HUMERUS PLATE AXSOS 3 FOR RIGHT HUMERUS 3 HOLE / L86MM
• 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: 23144615
• Report Number: 0008031020-2025-01636
• Device Sequence Number: 9915943
• Product Code: HRS
• UDI-Device Identifier: 07613327091243
• UDI-Public: (01)07613327091243(17)291130(10)AL9258
• 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): 11/26/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 627233S
• Device Lot Number: AL9258
• 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: 08/28/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2024
• 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 Sex: Unknown