MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/LEFT; PLATE,FIXATION,BONE

Catalog Number 02.124.411

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient information not available for reporting.(b)(4).Device is not expected to be returned for manufacturer review/investigation.Concomitant devices reported: therapy date is unknown.Screws - mix of cortical and locking screws (quantity# 10 to 12).Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was not returned and no lot number was provided.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional is obtained that was not available for the initial med-watch, the investigation will be updated as applicable, and a follow-up med-watch will be filed as appropriate.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 the patient underwent revision surgery due to a broken plate.The plate was originally implanted months earlier at another institution and consisted of a 4.5 mm variable angle (va) locking compression plate (lcp) curved condylar plate/ 10 hole/ 230 mm/ left and ten (10) to twelve (12) screws (mix of cortical and locking screws).It was reported that the plate broke into two (2) clean pieces.The plate and all screws were removed and the patient was revised to a femoral nail.The surgery was reported to be successfully completed.Patient outcome is unknown since the hospital did not wish to share any patient information.This complaint involves one (1) device.Concomitant devices reported: screws - mix of cortical and locking screws (part# unknown, lot# unknown, quantity# 10 to 12).This report is 1 of 1 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/LEFT
• Type of Device: PLATE,FIXATION,BONE
• 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: 7020559
• MDR Text Key: 91802571
• Report Number: 1000562954-2017-10246
• Device Sequence Number: 1
• Product Code: HRS
• 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: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention