MAUDE Adverse Event Report: SYNTHES MONUMENT 10MM TI CANNULATED FEMORAL NAIL 320MM-STERILE; IMPLANT, FIXATION DEVICE, SPINAL

Catalog Number 474.032S

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

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported that a patient underwent a hardware removal procedure on (b)(6) 2015 due to persistent pain (without infection) of the left hip.During the procedure, the following intact devices were removed: an antegrade femoral nail, an end cap, and three (3) 5.0mm locking screws.The procedure was completed successfully with a one (1) minute surgical delay due to a bent screwdriver.At this time, the patient has not been revised to a new device.This report is 1 of 3 for (b)(4).

Manufacturer Narrative

Additional patient information: patient height was reported as (b)(6).Patient initials are (b)(6).The patient¿s exact weight is reported as (b)(6).(expiry date): june 2010.The original implant procedure occurred on an unknown date approximately ten (10) years ago.The complaint part was returned to the patient and is not available for return.The investigation could not be completed; no conclusion could be drawn as no product was received.Device history review: manufacturing location: monument - manufacturing date: june 20, 2001 - expiration date: june 2010.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device 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

A corrected device history record review was completed: part number: 474.032s.Lot number: 4265721.Raw material number: 4122647.Manufacture date: 19june2001.Expiration date: 01june2010.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.

• Brand Name: 10MM TI CANNULATED FEMORAL NAIL 320MM-STERILE
• Type of Device: IMPLANT, FIXATION DEVICE, SPINAL
• 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: 4898657
• MDR Text Key: 6066017
• Report Number: 1719045-2015-10435
• Device Sequence Number: 1
• Product Code: JDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK954856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2010
• Device Catalogue Number: 474.032S
• Device Lot Number: 4265721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2001
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention