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

Catalog Number 02.124.412

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

Patient Problems Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: (b)(6).Event date: unknown.Additional device product codes are hrs and hwc.Date of implant is unknown.The subject device is not expected to be returned to the synthes manufacturer for evaluation and was reportedly discarded by the user facility.A device history record review was performed for the subject device lot.Manufacturing location: synthes (b)(4).Product manufacture date: aug 26, 2014.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 revision surgery was performed on (b)(6) 2016 due to nonunion of a femoral fracture.The patient originally had an open reduction internal fixation (orif) procedure for the femur fracture on an unknown date.During the initial procedure one (1) 4.5mm variable angle (va) locking compression curved condylar plate, five (5) unknown 5.0mm va cannulated locking screws, two (2) unknown 4.5mm cortex screws, and four (4) 5.0mm va locking screws were implanted.Per the revision surgeon, the initial surgery was not done very well and patient had a poor reduction leading to the nonunion.During the revision, all originally implanted devices were removed intact.The fracture site was debrided and reduced.New implants were placed using the 4.5mm va condylar plating system.The patient¿s outcome was reported as ¿okay¿.The surgery was successfully completed with no surgical delay.This report is 1 of 4 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT
• Type of Device: CONDYLAR PLATE FIXATION IMPLANT
• 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: 5880041
• MDR Text Key: 52252232
• Report Number: 1000562954-2016-10172
• 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
• Report Date: 08/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.412
• Device Lot Number: 9079986
• Other Device ID Number: (01)10886982042859(10)9079986
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/02/2016
• Initial Date FDA Received: 08/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 112