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

Model Number 3.0X130MM FIBULA NAIL, LEFT

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/08/2019

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was requested/is expected but has 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 a left ankle fracture procedure, the proximal end of the fib30130l fibula nail broke off during insertion and was left inside of the fibula.The rep stated the fracture was successfully reduced and fixated with a distal fibula plate and screws.The seated depth of the implant was 130mm.A 3.22mm was used to prep the bone.Additional information has been requested.Additional information received on (b)(6) 2019: the rep stated that the surgeon attempted to remove the broken fragment, but no avail.The rep confirmed the remaining portion of the nail was retrieved and will be returning for evaluation.The bone was prepped by using a 6.2 distal reamer and 3.2 proximal reamer.The rep stated that the surgeon had to switch to their back up plan to make a larger incision so they could plate the fracture.A second fib30130l was not brought in.The case was completed by using an ankle fracture plate.

Manufacturer Narrative

Complaint confirmed.The nose cone was found to have broken off from the device.The most likely cause is improper canal preparation, which caused the distal end of the device to become incarcerated into the unreamed canal and break when the implant was impacted.

• Brand Name: 3.0X130MM FIBULA NAIL, LEFT
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8479859
• MDR Text Key: 140814239
• Report Number: 1220246-2019-00998
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00816988011491
• UDI-Public: 00816988011491
• Combination Product (y/n): N
• PMA/PMN Number: K160069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/09/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2019
• Device Model Number: 3.0X130MM FIBULA NAIL, LEFT
• Device Catalogue Number: FIB30130L
• Device Lot Number: A091117-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Initial Date Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 04/03/2019
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 04/09/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 113