MAUDE Adverse Event Report:; NAIL, FIXATION, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6).This report is for one unknown 13mm tibial nail.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a patient underwent removal of a tibial nail and screws on (b)(6) 2016 due to non-union and infection.The patient was implanted with the tibial nail construct (nail and screws) approximately one (1) year ago by a different surgeon at a different facility.During the procedure, the surgeon removed one (1) 13mm tibial nail, one (1) 5.0 mm distal locking screw, and one (1) 5.0 mm proximal locking screw.All hardware was removed intact.Due to the infection, amputation of the leg was required.After the nail and leg were removed, the infection was cleaned out with a reamer-irrigator-aspirator (ria).The procedure was successfully completed with no surgical delay.The patient status was reported as stable.This report is for an unknown 13mm tibial nail.This report is 1 of 3 for complaint (b)(4).

• Type of Device: NAIL, FIXATION, BONE
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6211069
• MDR Text Key: 63472557
• Report Number: 2520274-2016-15781
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 72