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	Foreign Body In Patient (2687)
Date of Event	03/04/2021
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.
Event or Problem Description
It was reported that the long flexible wire from the ar-8973ds fibulock implant system was introduced and advance up the fibula.When the 3.2mm reamer was introduced and advanced up the fibula, the device came to a hard stop.When attempting to advance the 3.2mm reamer up the fibula further, the flexible wire that was being reamed over broke in half.The broken flexible wire was left in the fibula and the ar-8973l-30-130 fibulock nail was inserted per technique guide.The proximal tip of the fibulock nail came into contact with the broken end of the wire and as the fibulock nail passed by the broken wire, the proximal tip of the fibulock bent.The fibulock nail and flexible wire were both left in the fibula as the fracture was reduced and the doctor did not have a problem leaving it in the patient.

• 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: 11547674
• Report Number: 1220246-2021-02771
• Device Sequence Number: 16994855
• Product Code: HSB
• UDI-Device Identifier: 00888867303041
• UDI-Public: 00888867303041
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K173656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/22/2021

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: Health Professional
• Device Model Number: FIBULOCK IMPLANT SYSTEM, STERILE
• Device Catalogue Number: AR-8973DS
• Device Lot Number: 10763386
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 03/22/2021
• Patient Sequence Number: 1