MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/LEFT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.415

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 05/06/2016

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.(b)(4).Device has not been explanted yet; revision surgery is scheduled for an unknown date.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that variable angle condylar plate was used during an open fixation for a peri prosthetic femur fracture on the left leg of the patient on (b)(6) 2016.The patient returned to the hospital with a non-union and a broken implant.It was reported the implant broke on (b)(6) 2016, but information about the events surrounding the plate breakage are unknown.It was reported an revision procedure has been scheduled.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Revision procedure occurred on an unknown date and the device was explanted.Part 02.124.415, lot 9483095: manufacturing site: (b)(4).Manufacturing date: may 21, 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.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.

Manufacturer Narrative

The reported non-union occurred on an unknown date; however, it was noted that the device likely broke on (b)(6) 2016.Manufacturing investigation evaluation: the involved part was returned in a packaging different than the original.The information etched on the device matches with that provided by the reporter.The returned part is broken.The returned part was re-inspected for all the features pertinent to the complaint condition.The plate is broken at the va9 level of the plate; this hole is not measurable.Also, the holes 1-3-5-7-8-10-11-13 are not measurable due to the damages sustained post-production.The measurable holes closest to the fractured area (holes 2-4-6-12-14) were re-inspected and found to be conforming to specifications.Since all the plate holes are manufactured using the same cnc program, parameters, and tools it can be concluded that the features of the damaged holes were conforming to specifications.Considering that all relevant measurable product features met specification with no manufacturing-related visual defects identified, the conclusion of the product investigation is that the returned part is conforming from a manufacturing perspective.Therefore, the complaint is disposed as confirmed due to evidence that part is broken, but is considered not valid for (b)(4) because there is no evidence of manufacturing-related issues.Product investigation summary: unfortunately, the exact reason for this reported occurrence could not be determined; however, it is likely that post-operative activities of the patient and/or a possible instability of the fracture situation (non-union) played a role.No product fault could be detected.No corrective action required.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.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/LEFT
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5672696
• MDR Text Key: 45690002
• Report Number: 2520274-2016-12795
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2016

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.415
• Device Lot Number: 9483095
• Other Device ID Number: (01)07611819454118(10)9483095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention