MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/18HOLE/370MM/RT-STER; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.418S

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 10/23/2017

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient id, age and weight not provided for reporting.Additional product code: hwc, hrs.(b)(4).(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 02.124.418s / lot #l327059, manufacturing site: (b)(4), manufacturing date: 21.March 2017.Expiry date: 01.March 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 needed a revision on (b)(6) 2017 due to post-operative breakage of the plate.The devices were implanted on (b)(6) 2017 and the plate broke on (b)(6) 2017.The revision surgery was successfully and a nail was implanted.This complaint involves 1 part.Concomitant reported part: unknown screws.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A manufacturing investigation was performed for the subject device (4.5mm va-lcp curved condylar plate/18hole/370mm/rt-ster, part number 02.124.418s, lot number l327059).The subject device was returned to the manufacturer with the complaint condition stating the plate was broken at level of the variable angle fourth hole.The complaint is confirmed.Lot l327059 was manufactured in mar 2017.No ncrs were generated.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.Lot l327059 was manufactured starting from raw material lot 19961.The certificate of the raw material lot 19307 has been reviewed.In the relative certificate it is reported that the material is conforming.All the measurable features pertinent to complaint condition have been found conforming to specification.The plate is broken at the level of the holes number va.4 for this reason this hole is not measurable.The holes va.2/3/5/6/7 (the ones proximal to fracture line) were found conforming to specification for features that are still measurable.The plate thickness and width were measured in different points of the plate and found in specification.No evidence of nonconformance manufacturing related.No indication for material, manufacturing or design related issue was found.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/18HOLE/370MM/RT-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: 7039216
• MDR Text Key: 92372792
• Report Number: 1000562954-2017-10260
• 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: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 02.124.418S
• Device Lot Number: L327059
• 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: 11/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR