MAUDE Adverse Event Report: STRYKER GMBH VARIAX 2 WRIST FUSION WRIST FUSION PLATE SHORT BEND 123MM; PLATE, FIXATION, BONE

Catalog Number	629589
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "on (b)(6) 2024, the patient underwent surgery on his left wrist.It was fused using the variax 2 wrist fusion.In mid-(b)(6)2025, it was discovered that the plate had broken.The material was then removed on (b)(6) 2025.The patient reported pain in the wrist and a lack of strength in his dominant hand.".
Event or Problem Description
As reported: "on (b)(6) 2024, the patient underwent surgery on his left wrist.It was fused using the variax 2 wrist fusion.In (b)(6) 2025, it was discovered that the plate had broken.The material was then removed on (b)(6) 2025.The patient reported pain in the wrist and a lack of strength in his dominant hand.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation; however, based on the provided image, the alleged event could be confirmed.Based on the provided photographs, the plate appears to be fractured into two fragments originating from the slotted hole.Initial visual assessment of the images suggests that the fracture exhibits characteristics consistent with brittle failure, with no visible evidence of plastic deformation.A detailed evaluation of the fracture surface would require physical receipt of the product to complete the failure analysis.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: VARIAX 2 WRIST FUSION WRIST FUSION PLATE SHORT BEND 123MM
• 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: 24457741
• Report Number: 0008031020-2026-00244
• Device Sequence Number: 9403536
• Product Code: HRS
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: 629589
• Device Lot Number: AE4173
• Was Device Available for Evaluation?: No
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 59 YR
• Patient Sex: Male