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

Model Number 3.0X130MM FIBULA NAIL, RIGHT

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/15/2020

Event Type  Injury  

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 Description

It was reported during an open reduction internal fixation ankle fracture fibula repair the nail was inserted per technique, the surgeon did not like the position so he tried to remove it.During the removal it broke and the end cap remained in the patient.It was observed the talons of the implant were not open.The doctor replaced it with another nail and it was implanted with no issues but a portion of the first nail still remains in the patient.The procedure was completed.The doctor and the patient are planning to do a revision to remove the first partial nail.

• Brand Name: 3.0X130MM FIBULA NAIL, RIGHT
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 10366844
• MDR Text Key: 201686163
• Report Number: 1220246-2020-02004
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00888867295216
• UDI-Public: 00888867295216
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2020

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
• Device Operator: Health Professional
• Device Model Number: 3.0X130MM FIBULA NAIL, RIGHT
• Device Catalogue Number: AR-8973R-30-130
• Device Lot Number: 10584447
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/05/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other