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

Catalog Number 02.124.408

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient identifier, age, gender, weight not reported it is unknown when non-union and plate breakage occurred.Additional product codes: hrs, hwc.Implant date was reported as an unknown date in (b)(6) 2016.Device is unavailable for return.Original therapy date/surgery date unknown.Device history review was completed; manufacturing location: (b)(4) manufacturing date: october 16, 2014 no non-conformance records (ncrs) 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.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 was treated for a right distal femur fracture in (b)(6) 2016.Patient was implanted with a 4.5mm variable angle distal femur condylar plate, six (6) 5.0mm variable angle cannulated locking screws, four (4) 5.0mm variable angle locking screws and one 4.5mm cortex screw.It was noted on an unknown date that the patient had developed a non-union and the plate had broken postoperatively.The plate broke part way through over the second hole of the distal aspect of the plate.The plate did not break in half, only halfway through.There was no reported issue with the screws.Patient underwent revision surgery on (b)(6) 2016.All hardware was removed.The screws were intact upon removal.Patient was revised to a competitor's distal femur replacement device.There was no surgical delay and medical intervention was not required.Standard x-rays were taken (b)(6) 2016.Patient status is unknown.Concomitant devices reported: 5.0mm variable angle cannulated locking screws (part # unknown, lot # unknown, quantity of 6); 5.0mm variable angle locking screws (part # unknown, lot # unknown, quantity of 4); 4.5mm cortex screw (part # unknown, lot # unknown, quantity of 1).This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/RIGHT
• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6058197
• MDR Text Key: 58419862
• Report Number: 1000562954-2016-10206
• 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: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.408
• Device Lot Number: 9203605
• Other Device ID Number: (01)10886982042774 (10)9203605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CANNULATED LOCKING SCREW (PART # UNKNOWN, QTY 6); CORTEX SCREW (PART # UNKNOWN, QTY 1); LOCKING SCREWS (PART # UNKNOWN, QTY 4)
• Patient Outcome(s): Required Intervention