MAUDE Adverse Event Report: STRYKER GMBH CANCELLOUS SCREW AXSOS 3 Ø4.0MM / L70MM / FULL THREAD; PLATE, FIXATION, BONE

Catalog Number	607370
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event is rated as confirmed, since the visible damages indicate that there were multiple issue during the screw insertion.The device inspection revealed the following: one cancellous bone screw was returned without allegation, but during the visual inspection it was detected that the screw is strongly damaged.The first three thread flanks are totally flattened; this indicates that there was an very strong contact with another implant at the end of the screw insertion.In addition, there is a deep notch running across the thread on the shaft.This notch was most likely caused by the drill bit during pre-drilling for another screw.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.Based on investigation, the root cause was attributed to a user related issue.The event was caused by selecting a screw trajectory, with a path that led to a collision with other implants.If this event had an effect on the locking screws can in retrospective not be defined.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "a case where a patient experienced hardware failure after the initial operation.Plate hardware locking screws became prominent resulting in hwr surgery and eventually a total knee replacement on (b)(6) 2025".

• Brand Name: CANCELLOUS SCREW AXSOS 3 Ø4.0MM / L70MM / FULL THREAD
• 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: 23639410
• Report Number: 0008031020-2025-02102
• Device Sequence Number: 9258661
• Product Code: HRS
• UDI-Device Identifier: 07613252578673
• UDI-Public: (01)07613252578673(10)AE2069
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/24/2025

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: 607370
• Device Lot Number: AE2069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2023
• 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