MAUDE Adverse Event Report: STRYKER GMBH ONE-THIRD TUBULAR PLATE VARIAX2 5 HOLE / L59MM; PLATE, FIXATION, BONE

Model Number	626675
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Deformity/ Disfigurement (2360)
Date of Event	03/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information in this report was provided by stryker legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Retained by hospital.
Event or Problem Description
Patient stated she had a stryker external fixator implanted on left ankle on (b)(6) 2019 to move ankle over 30 degrees.On (b)(6) 2019 they removed the external fixator and implanted an internal fixator, plates and screws.Patient was cleared for physical therapy in december and continue pt for two months.On (b)(6) 2020 she was walking around her house and heard a pop.Patient went to the urgent care and they took x-rays which showed a broken plate, loose screws and her ankle went back to 45 degrees.Patient is experiencing pain, which has gotten worse these past two weeks.

• Brand Name: ONE-THIRD TUBULAR PLATE VARIAX2 5 HOLE / L59MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10368126
• Report Number: 0008031020-2020-02073
• Device Sequence Number: 16898420
• Product Code: HRS
• UDI-Device Identifier: 07613327088656
• UDI-Public: 07613327088656
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2020

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 Model Number: 626675
• Device Catalogue Number: 626675
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 83