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 Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Patient identifier and age or date of birth not available for reporting.Patient weight reported as (b)(6) kg.Date of device breakage is not known.Additional product code: hrs, hwc.(b)(4).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Dhr review was conducted.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Manufacturing site: (b)(4).Manufacturing date: 03.Sep.2015.Expiry date: 01.Aug.2025.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 the (b)(6) as follows: it was reported patient was implanted with a 4.5 mm variable angle locking compression curved condylar plate (va-lcp) on (b)(6) 2016.On unknown date it was determined the plate was broken.Patient was returned to surgery on (b)(6) 2016 and revised to a retrograde/antegrade femoral nail-ex (rafn).Surgery was completed successfully, patient reported to be fine.Concomitant devices reported: screw (part number unknown, lot number unknown, quantity unknown) this report is for one (1) 4.5 mm va-lcp curved condylar plate.This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

A manufacturing investigation was performed.Part is not received in the original packaging.Part and lot number etched on products match to complaint device and dhr.Plate broke at level of holes va3/va4.Per complaint description a plate broke post-operatively.The certificates of the related raw materials used to manufacture the plate have been reviewed.Lot 9615602 was manufactured starting from raw material lot 18831.Per relevant certificates the material is conforming.The raw material has been verified through review of certificate documented in the dhr review section.The returned plate was re-inspected for all the features pertinent to the complaint condition according to the product investigation matrix ¿broken/cracked¿ reported in the procedure.The plate is broken at the level of the holes va-3/va-4.The holes va-1/2/5/6 (the ones proximal to fracture line) were found conforming to specification for features that are still measurable.For these features, since the va-holes are manufactured using the same cnc program and tools (repeated features), it is possible to conclude that all variable angles holes were conforming to spec.The plate thickness was measured in different points of the plate and found in specification.No evidence of nonconformance manufacturing related.Considering that all relevant measurable product features meet specification and no visual defects manufacturing related have been identified on returned item, the conclusion of the product investigation is that the returned part is conforming from a manufacturing perspective.Complaint is confirmed due to evidence that part is broken, but it's considered not valid from manufacturing point because there is no evidence of manufacturing related issues.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.

• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6786564
• MDR Text Key: 82457603
• Report Number: 1000562954-2017-10172
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2017

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.413S
• Device Lot Number: 9615602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2017
• Initial Date FDA Received: 08/10/2017
• Supplement Dates Manufacturer Received: 08/18/2017
• Supplement Dates FDA Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention