MAUDE Adverse Event Report: ARTHREX INC. 3.0X130MM FIBULA NAIL, LEFT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	FIB30130L
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was requested/is expected for evaluation but has not yet been received.Device history record review revealed nothing relevant to this event.The device was requested and is expected for evaluation but has not yet been received.The cause of the event could not be determined from the information available and without device evaluation.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported during a case that the 3.0x130mm fibula nail, left broke off in the fibula as the nail was being driven in.This happened prior to having to deploy the talons.The surgeon reamed to proper depth with both the 6.2 and 3.2 drill.The surgeon had to cut the proximal portion of the nail to get the nail in.Follow-up investigation: per sales rep the case was completed by cutting the nail short and finishing the case per surgical technique.No further issues reported.

• Brand Name: 3.0X130MM 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: 6975638
• Report Number: 1220246-2017-00399
• Device Sequence Number: 1130269
• Product Code: HSB
• UDI-Device Identifier: 00816988011491
• UDI-Public: 00816988011491
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 10/25/2017

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: 12/01/2018
• Device Catalogue Number: FIB30130L
• Device Lot Number: CU180117-02
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 10/25/2017
• 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