MAUDE Adverse Event Report: STRYKER GMBH DISTAL ANTEROLATERAL TIBIA PLATE AXSOS 3 TI FOR RIGHT TIBIA 4 HOLE / L102MM; PLATE, FIXATION, BONE

Catalog Number	627484S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Date of Event	10/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "treated an emergency with the ankle joint open and dislocated, and lower it.On (b)(6) 2019, the internal fixation was added.Since the second half of the year has passed, he was overloaded.A follow-up examination confirmed the breakage.It was a fusion failure.Scheduled for re-operation on (b)(6) 2019.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event, patient¿s medical records as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "treated an emergency with the ankle joint open and dislocated, and lower it.On (b)(6) 2019, the internal fixation was added.Since the second half of the year has passed, he was overloaded.A follow-up examination confirmed the breakage.It was a fusion failure.Scheduled for re-operation on (b)(6) 2019.".

• Brand Name: DISTAL ANTEROLATERAL TIBIA PLATE AXSOS 3 TI FOR RIGHT TIBIA 4 HOLE / L102MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9313524
• Report Number: 0008031020-2019-01628
• Device Sequence Number: 18949658
• Product Code: HRS
• UDI-Device Identifier: 07613327082173
• UDI-Public: 07613327082173
• Combination Product (Y/N): N
• PMA/510(K) Number: K181091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2020

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?: No
• Operator of Device: No Information
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 627484S
• Device Lot Number: Y21749
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 01/10/2020
• 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