MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM; SCREW, FIXATION, BONE

Catalog Number	657312
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Erosion (1750); Foreign Body Reaction (1868)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "surgeon advised he was removing one of our variax fibula plates that he had implanted 5 years prior & at the plate bone interface as per attached photo there was "gross metallosis" and "pretty bad bone erosion" plate and screws have been successfully removed & will be returned once decontaminated.Swabs have been sent to local pathology.".
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "surgeon advised he was removing one of our variax fibula plates that he had implanted 5 years prior & at the plate bone interface as per attached photo there was "gross metallosis" and "pretty bad bone erosion" plate and screws have been successfully removed & will be returned once decontaminated.Swabs have been sent to local pathology.".
Additional Manufacturer Narrative
Please note correction to d4 (catalog #, lot #, and gtin).The reported event could be confirmed with the provided images in which signs of metallosis and bone erosion are evident.The device inspection revealed the following: all the screws and plate were visually inspected, slight discoloration in the plate and screws was observed, holes of the implant plate and hexagonal recess of the screw heads were slightly deformed indicating application of excess torsional force which also has resulted in the stripping of the threads of the screw.However, it is not feasible to determine whether this has happened during implantation or explantation of the implants.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.In this case, the opinion of a medical expert was request to determine the root cause of the reported metallosis.His statement based on the information provided states: "the literature talks about the varying corrosive effects of anodized titanium, relating to the thickness and color of the anodized layers.At a fracture site, wolff¿s law is occurring with a generation of an electrical current, although very slight, the current occurs within the solutions around the plate and soft-tissue and will corrode to metal surface.It is the interaction of an inorganic material, and soft tissue and the degree of roughness of the implant surface, the methods utilized in achieving the surface topography, and the chemistry of implant materials, are some of the factors that may affect the soft tissue response of the plate to the adjacent soft tissue and create the grayish color.There has been no risk reported with this corrosive action since the levels of local metal ions and systemic ions is usually at very low levels in these cases.In case of high levels of metal ions, risks have been reported associated with local soft tissue damage, delayed hypersensitivity reaction (type iv) and systemic toxicity.As a summary, the appearance of the metallosis can be attributed to patient factors.Indeed, it is the result of how the patient reacted to the device.¿ based on hcp opinion during investigation, the root cause was attributed to a patient related issue as mentioned above.If more information is provided, the case will be reassessed.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM
• Common Device Name: SCREW, 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: 22700655
• Report Number: 0008031020-2025-01318
• Device Sequence Number: 15689522
• Product Code: HWC
• UDI-Device Identifier: 07613327086812
• UDI-Public: (01)07613327086812(10)Y17493
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: 657312
• Device Lot Number: Y17493
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2018
• 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: 66 YR
• Patient Sex: Unknown