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

Catalog Number 02.124.411S

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient age and dob not provided for reporting.Additional product codes: hrs, hwc (b)(4).Device is not expected to be returned for manufacturer review/investigation.Concomitant devices reported: 4.5 mm cortex screws (quantity 7), 5.0 mm locking screws (quantity 7).(b)(4).The device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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 underwent a hardware removal and revision on (b)(6) 2017 due to a broken 4.5 variable angle condylar plate.The original surgery to repair a distal third femur fracture was performed on (b)(6) 2015.Removed hardware included: one (1) broken 4.5 variable angle condylar plate, seven (7) 4.5 intact cortex screws and seven (7) intact 5.0 mm locking screws.There was a reported thirty (30) minute surgical delay related to the removal of one of the cortex screw which broke during explantation.The patient was revised to a retrograde femoral nail, two screws and a locking cap.The procedure was completed successfully with the patient in stable condition.This complaint involves one device concomitant devices reported: 4.5 mm cortex screws (part #unknown, lot #unknown, quantity 7), 5.0 mm locking screws (part #unknown, lot #unknown, quantity 7).This report will address the hardware removal and revision only.The intraoperative event will be captured in and reported under (b)(4).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: a device history record review was performed for the subject device lot.Manufacturing location: (b)(4), manufacturing date: 07.Nov.2014; expiry date: 01.Nov.2024.No non-conformances 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.(b)(4).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/10HOLE/230MM/LT-STER
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico PA 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: 6312149
• MDR Text Key: 66822595
• Report Number: 2520274-2017-10416
• Device Sequence Number: 1
• Product Code: JDP
• 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,Followup
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.411S
• Device Lot Number: 9216289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 118