MAUDE Adverse Event Report: ARTHREX, INC. ANTEROLAT DIST TIB PLT, SS, LEFT, 12H; PLATE, FIXATION, BONE

Model Number	ANTEROLAT DIST TIB PLT, SS, LEFT, 12H
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the implanted plate broke four weeks after the initial surgery.A revision surgery was performed on (b)(6) 2019.The surgeon has used a nail to successfully perform the surgery.Additional information 14-jan-2020: further information were received that the initial procedure was a revision tibia & fibula fracture surgery.
Additional Manufacturer Narrative
Complaint confirmed, the plate broke in two pieces.Likely causes of the event include patient non-compliance or non-union of the tibia.Per the directions for use: "post-operatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.The fixation provided by this device should be protected.The post-operative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device.".

• Brand Name: ANTEROLAT DIST TIB PLT, SS, LEFT, 12H
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9631820
• Report Number: 1220246-2020-01614
• Device Sequence Number: 502714
• Product Code: HRS
• UDI-Device Identifier: 00888867223097
• UDI-Public: 00888867223097
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151732
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

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: Health Professional
• Device Model Number: ANTEROLAT DIST TIB PLT, SS, LEFT, 12H
• Device Catalogue Number: AR-8963AL-12
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 03/26/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other