MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/RIGHT; PLATE,FIXATION,BONE

Catalog Number 02.124.408

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported that a patient underwent a revision of a right distal femur fracture due to a failed non-union plate breakage that was originally done on an unknown date in (b)(6) 2014.It was also reported that reapplication of plate was done with bone grafting.The patient outcome was reported as fine.No other information is available at this time.There was no surgical delay reported and the procedure was completed successfully.This report is 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional product code for this report includes: hrs, hwc.The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.A review of the device history records was performed and no complaint related issues were found.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: an evaluation was performed on the returned device.As per received condition of device; the one returned plate etched and identified as lot #8505536.The plate is broken at va3 hole level.No visual defect related to the manufacturing process.The holes va3, va5 and va7 visually damaged post production.The plate has been reinspected for the features pertinent to the claimed issue.All relevant measurable product features meet specification with exception of the holes va 3, va5, va7 which is damaged (post production) all the holes are manufactured with the same parameters and tools the conclusion of the product investigation is that the complained part is conforming from a manufacturing perspective.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: a product evaluation was performed.The investigation of the complaint articles indicates that the: macroscopic examination of the implant; fractographic examination of the implant; electron microscopic examination of the implant; destructive testing denied on date (b)(4) 2014 on (b)(4).We were unable to identify any material defects based on our inspections/testing.The reason for the damage to the plate could not be determined with accuracy.The va-lcp curved condylar plate in question has become fatigued due to cyclic loading.The character of the fracture face in terms of topography and the existence of macroscopic secondary cracks as well as the crack in the 7th distal hole near the breakage indicate that the plate was exposed to a high stress level which caused the failure of the implant.The cause of fracture cannot be determined definitely.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.

Event Description

It was determined that the plate broke at a screw hole.It is unknown if there was a screw located in the broken screw hole.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Additional narrative: implant date reported as (b)(6) 2014.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/RIGHT
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3973821
• MDR Text Key: 4631921
• Report Number: 1000562954-2014-10146
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.408
• Device Lot Number: 8505536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2014
• Initial Date FDA Received: 08/01/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 09/29/2014; 12/11/2014; 12/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 118