MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/LEFT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.409

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Non-union Bone Fracture (2369); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.Date of event: unknown.Additional product codes for this report include hrs and hwc.The original implant procedure was performed on an unknown date in (b)(6) 2015.The complainant parts are not expected to be returned for manufacturer review/investigation.Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history record review: manufacturing location: (b)(4) - manufacturing date: february 2, 2015.No non-conformance reports 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.Device 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

It was reported that a patient was implanted with a plate, four (4) 5.0mm cannulated locking screws, five (5) solid variable angle (va) locking screws, and one (1) 4.5mm cortex screw in (b)(6) 2015 to treat a broken femur.Postoperatively, the fracture line showed signs of healing, but the fracture itself remained unstable and unhealed.Subsequently, the patient was revised on (b)(6) 2016 due to impaired healing and non-union.The surgeon reportedly removed all of the original implants intact.The fracture was then fixated with a longer plate and screws from the same 4.5 condylar plate system.In addition to the new hardware, the surgeon also infused the bone and performed a bone graft from reamer, irrigator, aspirator (ria) material and cancellous bone chips.This report is 1 of 4 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/LEFT
• 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: 5673695
• MDR Text Key: 45717455
• Report Number: 1000562954-2016-10116
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.409
• Device Lot Number: 9337438
• Other Device ID Number: (01)10886982042798(10)9337438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention