MAUDE Adverse Event Report: ARTHREX, INC. 3.8X180MM FIBULA NAIL, LEFT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3.8X180MM FIBULA NAIL, LEFT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2019
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 device was reported to have been discarded.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 during a ankle arthroscopy procedure, after the surgeon advanced the fibula nail, ar-8973l-38-180, into the distal portion of the fibula, the surgeon had to pull the nail back to re-align the distal portion with the proximal portion of the fibula.When he retracted the nail back the head of the nail broke.The case was completed by plating after the incident.*additional information requested.Additional information provided 1/25/2019: this was a fibula fracture repair procedure.The tip of the nail broke but did not detach from the rest of the device; therefore, no fragments remained in the patient.An additional incision was created for the insertion of the plate.

• Brand Name: 3.8X180MM FIBULA NAIL, LEFT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8344553
• Report Number: 1220246-2019-00902
• Device Sequence Number: 1058073
• Product Code: HSB
• UDI-Device Identifier: 00888867295261
• UDI-Public: 00888867295261
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K173656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/15/2019

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 Expiration Date: 10/31/2023
• Device Model Number: 3.8X180MM FIBULA NAIL, LEFT
• Device Catalogue Number: AR-8973L-38-180
• Device Lot Number: 10252394
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 02/15/2019
• 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: Other