MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW AXSOS 3 Ø3.5MM / L22MM; PLATE, FIXATION, BONE

Catalog Number	661422
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	01/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Patient presented in er from a gsw to distal humerus on (b)(6) 2024.Taken to surgery for an orif with pangea extra-articular humeral plate and variax minifrag.Surgery was successful with post op x-rays to show correct alignment and utilization.Patient was discharged appropriately but then got into multiple altercations (fist fights) over the first few weeks's post op.Patient also stated he made attempts to remove his cast at home.He also tried to start a physical altercation with an ortho pa at his follow-up appointment.The patient was brought back to surgery for a revision on (b)(6) 2025.No infection was present.Hardware showed signs of failure with broken plate, broken screws, and a locking hole failure.Appears the locking screw migrated through the hole of the plate.
Additional Manufacturer Narrative
Please note the corrections to d1, d2b, d2a, d4 catalog # and h6 clinical code.The reported event could be confirmed during the investigation.The device inspection revealed the following: the identification of the returned screw could be confirmed based on the catalog number and lot number marked.The screw is broken at the threads just below the head, the detached shaft has not been returned for inspection.Rest lines can be observed on the surface breakage, giving indication of a fatigue fracture resulting from excessive continuous load.The presence of a sudden ¿catastrophic¿ fracture give evidence that the implant failed under high traumatic load.It must be noted that the inspection of the devices was only performed for procedural reasons.The information provided already gives the root cause of the screw breakage."patient was discharged appropriately but then got into multiple altercations (fist fights) over the first few weeks post op.Patient also stated he made attempts to remove his cast at home.He also tried to start a physical altercation with an ortho pa at his follow-up appointment." the patient's post-operative behavior was undoubtedly the cause of the construction's failure, as it made any bone healing impossible.No orthopedic implant assembly could have been robust enough to withstand such stress in such a short time after implantation.As a reminder, violence should be avoided in all circumstances and at all times and the weeks following the implantation of an orthopedic device are no exception.The instructions for use clearly indicate the instructions for post-operative control and patient behavior required for a successful implantation and fracture healing.Fist fights and physical altercations with an orthopedic physician assistant are not among them.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.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.
Event or Problem Description
Patient presented in er from a gsw to distal humerus (b)(6) 2024.Taken to surgery for an orif with pangea extra-articular humeral plate and variax minifrag.Surgery was successful with post op x-rays to show correct alignment and utilization.Patient was discharged appropriately but then got into multiple altercations (fist fights) over the first few week's post op.Patient also stated he made attempts to remove his cast at home.He also tried to start a physical altercation with an ortho pa at his follow-up appointment.The patient was brought back to surgery for a revision on (b)(6) 2025.No infection was present.Hardware showed signs of failure with broken plate, broken screws, and a locking hole failure.Appears the locking screw migrated through the hole of the plate.

• Brand Name: CORTEX SCREW AXSOS 3 Ø3.5MM / L22MM
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21734866
• Report Number: 0008031020-2025-00494
• Device Sequence Number: 12920507
• Product Code: HRS
• UDI-Device Identifier: 07613252580324
• UDI-Public: (01)07613252580324(11)231219(10)AF0267
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K222381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

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: 661422
• Device Lot Number: AF0267
• 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: 01/14/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• 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