MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/RIGHT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.410

Device Problems Bent (1059); Break (1069)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).Broken plate was implanted on an unknown date.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 was conducted.The report indicates that the: manufacturing location: (b)(4).Manufacturing date: june 16, 2015, no ncrs were generated during production.Review of the device history record(s) 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 a revision surgery was performed because of a non-union on (b)(6) 2015 to remove a broken 4.5mm va-lcp curved condylar plate/10 hole/230mm/right.The lcp curved condylar plate, implanted on an unknown date, was discovered broken with the use of x-rays and a surgery was scheduled to remove the broken implant and revise the non-union.There was no delay in surgery and the patient remained in good health post-surgery.This report is 1 of 1 for com-(b)(4).

Manufacturer Narrative

Product investigation summary: the following device(s) were received: 4.5mm va-lcp curved condylar plate (part # 02.124.410 | lot # 9508534) eleven (11) intact screws ¿ part numbers: 02.231.670 (x2), 02.231.665, 02.231.655, 02.205.270, 214.836 (x4), 214.834 (x2).A total of twelve (12) implants were received.The plate was severely bent and nearly broken into two pieces at the fourth combi-hole from the head portion of the plate.An inspection of the fracture site shows material homogeneity.The received screws were intact and functionally undamaged.Although the exact cause for the complaint condition cannot be determined, it is likely that excessive, cyclic loading due to insufficient/delayed bone healing resulted in the plate bearing the entire functional load of the patient.A visual inspection and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.The 4.5mm va-lcp curved condylar plate is indicated for buttressing multi-fragmentary distal femur fractures including: supracondylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, non unions and malunions.Proper use for the device(s) is addressed in the technique guide.The relevant drawings for the device(s) were reviewed.No drawing issues or discrepancies were noted.The design was determined to be suitable for the intended use when employed and maintained as recommended.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/10 HOLE/230MM/RIGHT
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5367071
• MDR Text Key: 35966341
• Report Number: 1000562954-2016-10009
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.410
• Device Lot Number: 9508534
• Other Device ID Number: (01)10886982042811(10)9508534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention