MAUDE Adverse Event Report: SYNTHES MONUMENT 11MM TI CANN TIBIAL NAIL-EX W/PROX BEND 375MM-STERILE; NAIL FIXATION BONE

Catalog Number 04.034.555S

Device Problem Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that a drill bit would not pass through a nail when drilling for a proximal screw during a suprapatellar tibial nailing procedure.All connections were checked and verified tight.The surgeon had to manipulate the guide and push up on the drill bit and guide in order for the bit to pass through the nail.There was a fifteen minute surgical delay.The screw went in successfully and the procedure was completed without harm to the patient.This is report 7 of 7 for (b)(4).

Manufacturer Narrative

A review of depuy synthes monument device history records for manufacturing revealed no complaint related issues.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.

Manufacturer Narrative

Device has not been reported as explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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.

• Brand Name: 11MM TI CANN TIBIAL NAIL-EX W/PROX BEND 375MM-STERILE
• Type of Device: NAIL FIXATION BONE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4557147
• MDR Text Key: 5552079
• Report Number: 1719045-2015-10137
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK040762
• 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,Followup
• Report Date: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Catalogue Number: 04.034.555S
• Device Lot Number: 7618288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 81