MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/RIGHT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.416

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

Patient Problems Unspecified Infection (1930); Irritation (1941); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Additional patient information: patient height reported as (b)(6).Patient id number: (b)(6).Additional product codes for this report include: hrs and hwc.Per facility, the complainant parts will not be returned for investigation as they were sent for testing within the hospital due to patient infection.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: may 11, 2015.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.

Event Description

It was reported that a patient underwent a hardware removal procedure on (b)(6) 2016 due to the identified post-operative movement of three (3) 5mm variable angle (va) locking screws.The patient was originally treated for a distal femur fracture on (b)(6) 2016 with the implantation of one (1) va-locking compression plate (va-lcp), five (5) 5mm va locking screws, five (5) 4.5mm cortical screws, two (2) 3.5mm non-locking screws, and two (2) washers.On an unknown post-operative date, the patient presented with pain and irritation at the fracture site.X-ray images revealed that three (3) of the 5mm va locking screws had backed out from the distal portion of the plate.As a result, the patient returned to the operating room on (b)(6) where all of the original hardware was successfully removed intact.During the procedure, however, an infection was identified in the patient¿s leg.The surgeon suspected that the movement of the screws may have also contributed to the development of the infection.The explanted devices were sent for further analysis within the hospital.The patient was then treated with external fixation.The procedure was completed successfully with no reports of delay or additional intervention.Post-operatively, the patient was said to be stable.This report is 1 of 7 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/RIGHT
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5972824
• MDR Text Key: 55448899
• Report Number: 1000562954-2016-10185
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.416
• Device Lot Number: 9466622
• Other Device ID Number: (01)10886982042934(10)9466622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 94