MAUDE Adverse Event Report: ARTHREX, INC. FIBULOCK IMPLANT SYSTEM, STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	FIBULOCK IMPLANT SYSTEM, STERILE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a procedure, the 3.2 proximal reamer and gold tip wire broke inside the mid shaft of the patients fibula.The surgeon was able to removed the 3.2 proximal reamer from the patient but was unable to remove the tip of gold wire that broke.The surgeon then opted to plate the fibula due to this issue.

• Brand Name: FIBULOCK IMPLANT SYSTEM, STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12076013
• Report Number: 1220246-2021-03328
• Device Sequence Number: 17069952
• Product Code: HSB
• UDI-Device Identifier: 00888867303041
• UDI-Public: 00888867303041
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: FIBULOCK IMPLANT SYSTEM, STERILE
• Device Catalogue Number: AR-8973DS
• Device Lot Number: 12281386
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1