MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/16HOLE/336MM/LT-STER; IMPLANT, FIXATION DEVICE CONDYLAR PLATE

Catalog Number 02.124.417S

Device Problem Bent (1059)

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

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: event date: unknown.Additional device product codes are hrs and hwc.(b)(4).(b)(6).The subject device has been received and is currently in the evaluation process.A device history record review was performed for the subject device lot number.Manufacturing location: synthes (b)(4).Date of manufacture: mar 18, 2016.Expiration date: mar 1, 2026.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 europe reported an event in (b)(6) follows: it was reported that revision surgery was performed on (b)(6) 2017 due to loss of reduction and plate integrity.The initial open reduction and internal fixation (orif) procedure was performed on the patient¿s distal femur on (b)(6) 2016.Follow up x-ray taken on (b)(6) 2017, showed a slight bend in the variable-angle-locking compression plate (va-lcp) condylar plate.Follow up x-ray taken on (b)(6) 2017 showed a significant bend in the va-lcp condylar plate.Revision orif distal femur case was performed on (b)(6) 2017 due to the loss of reduction due to loss of plate integrity.In discussions during the case the surgeon said the distal locking screws were sitting proud and no longer locked into the plate.He felt that the bridged distance around the fracture site was too large and that the independent cortex screws were not needed.Revision was to another 16-hole va-lcp curved condylar plate.The patient had normal post-operative recovery.Concomitant devices: cortex screw 2x (part 214.842/ lot: 9773409+ 204.838.Lot.2404492).This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: a manufacturing evaluation was completed: the plate is significantly bent.Dhr review: lot 9858279 was manufactured in march 2016.No scrap was generated during production.The inspections performed according passed: the functionality of the plates with their respective aiming arm was controlled 100% at milling operation and no non-conformances have been reported.No non-conformance reports 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.In the certificate of raw material it is reported that the material fulfills the specification.The returned part was re-inspected for all the features pertinent to the complaint condition.The plate is significantly bent in the distal portion of the plate al level of the holes where it should be flat.The holes closest to the bending area and one hole on the proximal portion of the plate have been re-inspected and found conforming to specification.Since all the holes are manufactured in the same production step, it can be stated that also the holes in the bent areas were in specification.The plate thickness and width have been measured in different points of the plate and found in specification too.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.No manufacturing related issue was identified.Complaint is disposed as confirmed due to evidence that part is bent, but it's considered not valid for manufacturing site because there is no evidence of issues manufacturing related.Unfortunately we are not able to determine the exact reason for this occurrence.A product investigation was completed: in additional to the plate, 10 va locking screws (part 02.231.242, lot l053067, quantity 2; part 02.231.242, lot 9856271, quantity 2; part 02.231.300, 9530481, quantity 2; part 02.231.295, lot 9804639, quantity 1; part 02.231.295, lot 9942467, quantity 1; part 02.231.290, lot 9951705, quantity 1; part 02.231.290, lot 9859213, quantity 1) were also received.Upon visual inspection, it was noted that all screws are damaged at the screw head thread, also some of the screws are damaged at shank.The device history records (dhr) for these articles and lot numbers were reviewed and there were manufactured according to specifications with no issues or deviations during the process.No non-conformance reports were marked in the dhr during production.It is unknown which of the va locking screws it was loosened postoperatively.Unfortunately we are not able to determine the exact reason for this occurrence; however, it is likely that the screw/screws backed out due to the damage (screw head thread) from insertion.Two concomitant cortex screws (part 214.842, lot 9773409 and part 204.838, lot 2404492) were received and it was determined these parts are not responsible for the plate bending and not backed out.It was noted that the plate deformation could be confirmed when the x-rays were reviewed by the manufacturer.No product fault could be detected.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/16HOLE/336MM/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: 6354488
• MDR Text Key: 68208397
• Report Number: 1000562954-2017-10018
• 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: 01/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.417S
• Device Lot Number: 9858279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 204.838, 3.5MM CORTEX SCREW 38MM, QTY 1; 214.842, 4.5MM CORTEX SCREW 42MM, QTY 1
• Patient Outcome(s): Required Intervention