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 Problem Break (1069)

Patient Problems Failure of Implant (1924); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Additional product codes: hrs and hwc.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Manufacturing location: (b)(4) manufacturing date: january 11, 2016.No non-conformance reports 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

It was reported the patient had a broken plate and a non-union.The patient had a right intramedullary nailing revision/hardware removal surgery on (b)(6) 2016.The implant date was unknown.The broken plate was removed with unknown locking and cortical screws which were removed intact.A lateral entry femoral nail and three (3) screws were implanted.There was no surgery delay or fragments noted.The procedure was successful and the patient outcome was reported as good.Concomitant devices reported: locking screw.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device returned to manufacturer.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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

A product development investigation was performed.This complaint is confirmed.The plate was received at customer quality (cq) broken as reported.The transverse break exists mid-combi hole (third combi hole distal to condylar plate region).Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken.The plate thickness nearest the break measured at cq on both plate pieces and found to be within specification.The plate width nearest the break measured at cq on both plate pieces and found to be within specification.A visual inspection under 5x magnification, dimensional inspection, device history record (dhr) review, and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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.Relevant drawings were reviewed.No drawing issues or discrepancies were noted.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.Unable to determine a definitive root cause.Most likely due to early excessive mobilization.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/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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6251029
• MDR Text Key: 64790145
• Report Number: 1000562954-2017-10003
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982042811
• UDI-Public: (01)10886982042811(10)9787557
• 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: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• 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: 9787557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 91