MAUDE Adverse Event Report: STRYKER GMBH DISTAL ANTEROLATERAL TIBIA PLATE AXSOS 3 TI FOR LEFT TIBIA 6 HOLE / L127MM; PLATE, FIXATION, BONE

Model Number 627456

Device Problem Fracture (1260)

Patient Problems Pain (1994); Injury (2348); Deformity/ Disfigurement (2360)

Event Date 03/01/2020

Event Type  Injury  

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 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 (b)(6) 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: DISTAL ANTEROLATERAL TIBIA PLATE AXSOS 3 TI FOR LEFT TIBIA 6 HOLE / L127MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: kevin smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10368028
• MDR Text Key: 201720534
• Report Number: 0008031020-2020-02072
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327082005
• UDI-Public: 07613327082005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 627456
• Device Catalogue Number: 627456
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 83