MAUDE Adverse Event Report: Stryker GmbH VariAx 2 One-Third One-Third Tubular Plate 7 Hole / L83mm; Plate, Fixation, Bone

Catalog Number	626677S
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, severe pain was observed following the wearing of a water pack.An x-ray shows a fracture of the osteosynthesis hardware with displacement resulting from the fracture.Clinical outcome: surgical intervention.Actions taken for the patient: excision, bacterial culture, new osteosynthesis, probabilistic antibiotic therapy.
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.

• Brand Name: VariAx 2 One-Third One-Third Tubular Plate 7 Hole / L83mm
• 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 ; +1(201)831-5000
• MDR Report Key: 50355991
• Report Number: 0008031020-2026-01229
• Device Sequence Number: 10112063
• Product Code: HRS
• UDI-Device Identifier: 07613327088762
• UDI-Public: 07613327088762
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 08/20/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 626677S
• Device Lot Number: AP4377
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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