MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/LEFT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Model Number 02.124.419

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis patient id, age, dob and weight not provided for reporting.Additional product code: hrs, hwc.Device is not expected to be returned for manufacturer review/investigation.Device history records review was conducted.The report indicates that the: part# 02.124.419, lot# 9195289.Manufacturing location: (b)(4).Manufacturing date: 07.Oct.2014.No ncrs 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.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 removal of a variable angle (va) condylar plate on (b)(6) 2017 due to nonunion and a broken plate.The original surgery was conducted about six (6) weeks ago and the construct included a va condylar plate, an unknown cable to help with the periprosthetic femur fracture repair, two (2) 4.5 mm cortical screws, five (5) va cannulated locking screws and four (4) va locking screws.All parts but the plate were removed intact.The removal surgery was successful and uneventful.The patient was reported to be stable.It is unknown if the patient will be revised to another set of implants.Concomitant devices reported: cable (quantity# 1).The 4.5 mm cortical screws (quantity# 2).Va cannulated locking screws (quantity# 5).Va locking screws (quantity# 4).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/LEFT
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6973126
• MDR Text Key: 90082944
• Report Number: 1000562954-2017-10236
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982042996
• UDI-Public: (01)10886982042996(10)9195289
• 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: Other
• Type of Report: Initial
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.124.419
• Device Catalogue Number: 02.124.419
• Device Lot Number: 9195289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CABLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1); THE 4.5 MM CORTICAL SCREWS PART /LOT# UNKNOWN, QTY 2; VA CANNULATED LOCKING SCREWS PART /LOT# UNK, QTY 5; VA LOCKING SCREWS PART /LOT# UNK, QTY 4
• Patient Outcome(s): Required Intervention