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

Catalog Number 02.124.417

Device Problem Bent (1059)

Patient Problems Pain (1994); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Patient identifier was reported as (b)(6).Exact date of post-operative plate bending is unknown.Additional product codes for this report include hrs and hwc.Product investigation summary: one (1) 4.5mm va-lcp curved condylar plate (part: 02.124.417 / lot: 9218057) was returned for investigation.The returned device is intact, but it is bent approximately at the seventh combi-hole proximal to the head of the plate.There are also various scratches and marks on the plate consistent with implantation and removal.Fourteen (14) concomitant screws were also received with no complaint alleged against them.These devices were visually inspected with no issues found.The exact cause for the complaint condition could not be determined, but it is likely that the device was subjected to excessive forces and cyclic loading due to the bone not healing properly.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint condition is confirmed.The returned device is part of the 4.5mm va-lcp curved condylar plate system and is indicated for buttressing multi-fragment distal femur fractures.The relevant drawings were reviewed with no issues or discrepancies noted.The design, materials, and finishing processes were found to be appropriate for the intended use of these devices.A review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No new, unique, or different patient harms were identified as a result of this investigation.No manufacturing or design issues were noted during the investigation.Device history record review: manufacturing location: (b)(4) - manufacturing date: october 28, 2014.No anomalies were detected during device history record review.No non-conformance reports 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.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.

Event Description

It was reported that a patient underwent a revision procedure on (b)(6) 2016 following reports of pain and the identification of a bent plate.The patient was originally treated for a left femur fracture on (b)(6) 2016 with the insertion of a 4.5mm variable angle locking compression (va-lcp) curved condylar plate and screws.On an unknown post-operative date, the patient began experiencing pain at the fracture site as well as along the proximal femur.As a result, the patient was returned to the operating room for revision.During the procedure, the surgeon implanted a new plate.In order to prevent stress riser and further fracture of the proximal femur, the patient was also fixated with a lateral entry reconstruction nail (intramedullary) in the left femur and recon screw placement in the distal femur through the femoral neck.The procedure was completed successfully with no reports of delay.Post-operatively, the patient was said to be stable.Concomitant device(s) reported: 5mm va locking screws (part/lot: unknown / quantity: 12), 4.5mm cortex screw (part/lot: unknown / quantity: 1), and screw (part/lot: unknown / quantity: 1).This report is 1 of 1 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/LEFT
• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5878567
• MDR Text Key: 52195130
• Report Number: 1000562954-2016-10171
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.417
• Device Lot Number: 9218057
• Other Device ID Number: (01)10886982042958(10)9218057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN 5MM VA LOCKING SCREWS (X12)
• Patient Outcome(s): Required Intervention
• Patient Weight: 118