MAUDE Adverse Event Report: SYNTHES MONUMENT 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 456.318S

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

Patient Problems Bacterial Infection (1735); Staphylococcus Aureus (2058)

Event Type  Injury  

Manufacturer Narrative

Additional patient information: patient height reported as 4 feet 8 inches.Patient (b)(6).Date of post-operative onset of (b)(6) is unknown.Additional product codes for this report include hwc.(b)(4).The patient underwent a procedure on (b)(6) 2016 to address the infection only.The intact implants were not removed during this procedure.The complainant parts are not expected to be returned for manufacturer review/investigation.Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history record review: manufacturing location: (b)(4) - manufacturing date: april 10, 2015 - expiration date: february 28, 2024.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.The sterility documentation was reviewed and determined to be conforming.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.

Event Description

It was reported that a patient suffered an intra-trochanteric hip fracture and underwent an open reduction internal fixation (orif) procedure on (b)(6) 2016 to treat.During that procedure, the patient was implanted with a trochanteric fixation nail (tfn) and screws.On an unknown post-operative date, the patient presented with symptoms of infection, which was later confirmed to be mrsa at the incision site.The patient returned to the operating room on (b)(6) 2016 for irrigation and drainage of the wound.All of the original hardware was intact and, therefore, was not removed.The procedure was completed successfully with no reports of surgical delay or further patient harm.This report is 1 of 3 for (b)(4).

• Brand Name: 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: 5649842
• MDR Text Key: 45035091
• Report Number: 1719045-2016-10387
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK011857
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Catalogue Number: 456.318S
• Device Lot Number: 7964010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 54