MAUDE Adverse Event Report: SYNTHES MONUMENT 10MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE

Catalog Number 04.004.449S

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that a non-union occurred on an unknown date from the original 10mm ti cannulated tibial nail-ex/345mm-sterile implant surgery on (b)(6) 2013.The x-rays on (b)(6) 2014, reviled a non-union.A revision surgery was performed on (b)(6) 2014, removing and replacing all devices; removed devices were discarded postoperatively.The procedure was successful with no harm to patient.This is report 1 of 7 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The investigation could not be completed and no conclusion could be drawn, as no product was received.A review of the device history record has been performed.Device history records for lot, blank lot, and raw material lot numbers were all reviewed for this complaint and no related anomalies for this product lot.Placeholder.

• Brand Name: 10MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE
• Manufacturer (Section D): SYNTHES MONUMENT; 1101 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1101 synthes ave; monument CO 80132
• Manufacturer Contact: erik crooms ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3639083
• MDR Text Key: 4182943
• Report Number: 1719045-2014-00072
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Catalogue Number: 04.004.449S
• Device Lot Number: 7292321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2013
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 66