MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/LEFT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.409

Device Problem 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.Additional product codes: hrs, hwc.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Device history records review was conducted.The report indicates that the: part# 02.124.409 lot# 9139714, manufacturing location: (b)(4), manufacturing date: 09.Sep.2014.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 of the distal femur was performed on (b)(6) 2016.Patient had a non-union and broken plate.Patient was revised with a longer plate and new screws.All other hardware that was removed was reported to be intact.Surgery completed successfully, patient outcome stable.There is 1 device in this complaint concomitant devices reported: screws (part# unknown, lot number unknown, qty unknown).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The subject device is currently undergoing investigation; the results are pending completion.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(6).Product investigation summary: one (1) 4.5mm va-lcp curved condylar plate was returned for investigation.The device was received broken in two pieces at the second combi-hole proximal to the head of the plate.There are also numerous scratches and marks consistent with implantation and removal.A visual inspection of the fracture surface found no voids and/or discolorations that might indicate a material issue.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, functional test, and drawing review were performed as part of this investigation.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 drawing issues or discrepancies noted.The design, materials, and finishing processes were found to be appropriate for the intended use of these devices.Calipers were used for all dimensional inspections/measurements.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.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.The design is determined to be adequate for its intended use when used 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/8 HOLE/195MM/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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5884306
• MDR Text Key: 52378899
• Report Number: 1000562954-2016-10173
• 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,Followup,Followup
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.409
• Device Lot Number: 9139714
• Other Device ID Number: (01)10886982042798(10)9139714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/03/2016
• Initial Date FDA Received: 08/17/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/11/2016; 10/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 86