MAUDE Adverse Event Report: SYNTHES MEZZOVICO VA-LCP CONDYLAR PLATE 4.5/5.0 R 18HO L37; IMPLANT,FIXATION DEVICE, IMPLANT,FIXATION DEVICE,

Catalog Number 02.124.418S

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient id, dob & weight not provided for reporting.Additional product code: hrs, hwc.Other udi: (b)(4).Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Therapy dates for concomitant parts are unknown.The plate broke post-operative which required additional surgical intervention.Device history records review was conducted.The report indicates that the: 02.124.418s / l163680, manufacturing site: (b)(4), manufacturing date: 07.Nov.2016, expiry date: 01.Oct.2026.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

It was reported that the patient had an injury and on (b)(6) 2017 a variable angle (va) condylar plate was implanted.The plate broke post-operatively on (b)(6) 2017 and was revised on (b)(6) 2017.During the revision a second va condylar plate was implanted and the surgery was successfully.The patient is fine.The patient was complaining of leg pain and went to hospital on the (b)(6), then had an x-ray which showed the plate failure.This complaint involves 1 part concomitant reported parts: unknown screws, unknown cables.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Patient gender not available for reporting.Device received.Subject device has been received and is currently in the evaluation process.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

Device was used for treatment, not diagnosis.Date of report and date rec¿d by mfr: jul 12th, 2017 is the new date.A manufacturing investigation was performed for the subject device.According to the complaint description a plate broke post-operatively.Dhr review: lot l163680 was manufactured in nov 2016.All the inspections performed according to inspection sheet passed.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.The certificates of the related raw materials used to manufacture the plate have been reviewed.Lot l163680 was manufactured starting from raw material lot 19492.In the relative certificates, it is reported that the material is conforming.Product inspection : 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 w-m-s080.The plate is broken at the level of the hole va6 and damaged post production at level of hole va7.The holes va-4/5/8/9 (the ones closest 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 and with were measured in different points of the plate and found in specification.No evidence of non-conformance manufacturing related.The raw material has been verified through review of certificate documented in the dhr review section.Conclusion: 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.Disposition: mia is disposed as confirmed due to evidence that part is broken, but it's considered not valid for mezzovico because there is no evidence of issues manufacturing related.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Patient gender updated.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: VA-LCP CONDYLAR PLATE 4.5/5.0 R 18HO L37
• Type of Device: IMPLANT,FIXATION DEVICE, IMPLANT,FIXATION DEVICE,
• 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: 6755452
• MDR Text Key: 81471523
• Report Number: 1000562954-2017-10148
• 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,Followup,Followup
• Report Date: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.418S
• Device Lot Number: L163680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR