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

Catalog Number 02.124.413S

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Pain (1994); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Date of event: unknown.Additional product code: hrs, hwc.(b)(4).Date returned to manufacturer.(b)(6).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records was conducted.The report indicates that the: 02.124.413s lot.9265271, manufacturing location: (b)(4), manufacturing date: 05 december 2014, expiry date: 01 november 2024.No ncr's were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.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 on an event in (b)(6) as follows: it was reported that a female patient had a long proximal femoral nail antirotate (pfna) in her left femur on the (b)(6) 2015 and then had a periprosthetic fracture at the left distal femur under the tip of the nail about 3-4 weeks later.She then had a variable angle condylar plate and cables to repair this on (b)(6) 2015.This patient also broke her right femur some time later which also was repaired with an intramedullary nail.This leg has been painful recently and the patient has been relieving the pain by weight bearing on her left leg.X-rays taken at the beginning of (b)(6) 2016 show the plate and nail still intact but showing a non-union at the distal femur.Approx 10 days ago she suffered another periprosthetic fracture through the plate and nail.The break of the plate and nail was at the level of the proximal distal screw hole of the nail - at roughly the same level where the cable fastens in to the plate.Surgeon has removed cables, screws, plate and distal tip of nail - leaving the main length of the nail in-situ.Repaired again with another va condylar plate, cables and locking attachment plate on (b)(6) 2016.This complaint involves 2 parts.Concomitant reported parts: 1x cerclage cable (part 298.801.01 lot is either p203333, p152289 or p180968).1x positioning pin (part 298.803.01 lot is either 7667467, 7892986 or 7524864).1x locking screw (either part 02.231.250s lot 8991753, part 02.231.285s lot 8988993, part 02.231.285s lot 8995479 or part 02.231.280s lot 9163284).This report is 1 of 2 for (b)(4).

Manufacturer Narrative

A manufacturing evaluation was completed: the plate is broken apart at the second variable angle locking hole.Both pieces of the broken plate were sent back for evaluation.The relevant dimensions at the fracture zone of the plate were as far as possible checked and found to be in compliance with the technical drawings and specifications.The examination of the raw-material testing certificate and the manufacturing papers showed no deviations regarding, dimensions, material analysis, strength and structural stability.The values were in compliance with specifications and with the international standards.The fracture face is homogenous, which indicates material conformity.No product fault could be detected.The exact cause of this breakage can afterwards not be defined.Based on the provided information it is likely that the mentioned non-union in combination with the additional weight bearing due the pain in the other leg did lead to a fatigue failure.No manufacturing related issue was identified and/or confirmed.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

The plate and nail failure resulted in a major revision procedure.The surgery was very difficult and took two and half (2.5) hours which was seventy-five (75) minutes longer than anticipated.The surgeon will be keeping an eye on the patient for the next twelve to eighteen (12-18) months.To treat her right broken leg the surgeon used a lateral femoral nail.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/12HOLE/266MM/LT-STER
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5709606
• MDR Text Key: 46915104
• Report Number: 1000562954-2016-10127
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.413S
• Device Lot Number: 9265271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PART 02.231, LOCKING SCREW
• Patient Outcome(s): Required Intervention
• Patient Weight: 65