MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/12HOLE/266MM/RT-STER; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.412S

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

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 shows; the plate was received broken.Based on the topography of the fracture surfaces, it can be concluded that the plate was subjected to low dynamic bending loads (one sided).Constant dynamic bending loads led to the fatigue of the material, then to a first crack and subsequently to the overload, resulting in the fracture of the plate.The plate could not resist the applied force which finally led to the material overload / fatigue failure.No evidence of material or manufacturing defects was found.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes europe reports an event in germany as follows: it was reported that the variable angle locking compression plate (va-lcp) broke postoperatively for the second time.After first implantation on (b)(6) 2013 and first implant fracture on (b)(6) 2014.On (b)(6) 2014 a new plate was implanted, and then the plate broke again on (b)(6) 2014.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A device history review was conducted.The report indicates that this complaint is assessed as not related to sterilization.Thus, the mezzovico documents were reviewed with the following result: no anomalies were detected during device history record review.No ncrs were generated during production.Review of the device history record showed that 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.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/12HOLE/266MM/RT-STER
• 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: 4266687
• MDR Text Key: 13007579
• Report Number: 1000562954-2014-10206
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/01/2023
• Device Catalogue Number: 02.124.412S
• Device Lot Number: 8429129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/03/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 63