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

Catalog Number 02.124.415S

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.(b)(6) patient dob and weight not provided for reporting.Additional product code: hwc.(b)(4).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: part #02.124.415s / lot #l277909.Manufacturing site: (b)(4).Manufacturing date: 13.Feb.2017.Expiry date: 01.Feb.2027.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.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 on an event in (b)(6) as follows: it was reported that the patient had redness and pain after the initial open reduction and internal fixation surgery (orif) rx washout distal end and insertion of stimulant.No growth and the patient was fine after, presumed not infected, samples also all negative at revision.Post-operative the plate broke (b)(4).This complaint involves 5 parts.This report is 1 of 5 for (b)(4).

Manufacturer Narrative

A product development investigation was performed for the subject device.The manufacturing documents of all devices were the lot number was known were reviewed and no complaint related issues were found.The documents show that these devices were made out of implant grade material according to the norm iso 5832-1 for wrought stainless steel implants for surgery.The review of the manufacturing documents has shown that also the packaging and sterilization of the devices was made according to the specification.A visual inspection of the returned plate, connection screws and locking attachment plates was performed and there were no damages like sharp edges or burrs that could have caused the mentioned redness and pain.The only visible damage is the breakage, which is covered in (b)(4).The complaint is deemed unconfirmed as no product related issue could be detected.There is no indication that this complaint was product related.In general following statement from: no known surgical implant material has ever been shown to be completely free of adverse reactions in the human body.However long-term clinical experience of the use of the material referred to in this part has shown that an acceptable level of biological response can be expected when the material is used in appropriate applications.No product related issue could be detected.No evidence found that the redness and pain was device related.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/14HOLE/301MM/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: 7028327
• MDR Text Key: 91941369
• Report Number: 1000562954-2017-10253
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.415S
• Device Lot Number: L277909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR