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 Break (1069)

Patient Problems Loss of Range of Motion (2032); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient initials are: (b)(6).Date of event: unknown.Additional product codes: hrs, hwc.Device is not expected to be returned for manufacturer review/investigation.(b)(4): a plate broke postoperatively after ambulation, in addition, the patient had a non-union and delayed healing.Revision surgery was required to remove the broken plate and intact hardware, and further treat the patient.Device history records was conducted.The report indicates that the lot # 8649709 manufacturing location: (b)(4), manufacturing date: 04.Oct.2013.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 initially underwent for a plate fixation surgery at metaphyseal flare on (b)(6) 2016.The plate broke postoperatively after ambulation and it was also discovered that patient had a non-union and delayed healing.Patient underwent for revision surgery on (b)(6) 2016.The broken plate and unknown number of screws were explanted.Patient revised with retro grade femoral nail.The procedure was completed successfully with no surgical delay and any other medical intervention required.This complaint involves 1 device.Concomitant medical device reported: screws (part # unknown, lot # unknown, quantity # unknown).This report is 1 of 1 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5740030
• MDR Text Key: 47890802
• Report Number: 1000562954-2016-10133
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110354
• 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: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.416
• Device Lot Number: 8649709
• Other Device ID Number: (01)10886982042934(10)8649709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 118