MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/RIGHT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.414

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Impaired Healing (2378)

Event Type  Injury  

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the variable angle distal femur plate failed after approximately 1 month in situ.Patient suffered fall with increased leg pain.On x-ray plate and femur were broken.All screws intact.Revision fixation completed with new plate and screws as well as demineralized bone matrix (dbx) grafting.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.A device history review was conducted.The report indicates that the device history record was reviewed and found non conformant to good documentation practices for the lack of release signature of the blank dhr: this has no relation with the complained defect.No other anomaly was detected during dhr review.No ncrs were generated during production.There were no issues during the manufacture of the product that would contribute to this complaint condition.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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: an evaluation was performed on the returned device.A broken plate was received.Based on the topography of the fracture surface, the unilateral fracture and the further crack, we can conclude that the implant was subjected to high dynamic bending loads.Constant alternating load cycles led to the fatigue of the material, then to a first crack and finally to the overload respectively to the fatigue fracture of the condylar plate.The implant could not resist the applied force which finally led to the material overload i fatigue failure.A failure resulting from either a material defect or the manufacturing process can be excluded.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/14 HOLE/301MM/RIGHT
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• 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: 4272257
• MDR Text Key: 5230957
• Report Number: 1000562954-2014-10207
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.414
• Device Lot Number: 9056252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 100