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

Catalog Number 02.124.409S

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight not provided for reporting.Date of event: unknown.Additional product codes: hrs, hwc, other udi: (b)(4).Original implant date: (b)(6) 2015.Date returned to manufacturer 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 review was conducted.Dhr review for: part # 02.124.409s lot # 9223281, manufacturing location: (b)(4), manufacturing date: 14.Nov.2014 expiry date: 01.Nov.2024, no ncrs was 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 patient who underwent a repair of a distal femur on an unknown date in (b)(6) 2015.Post-operative x-rays showed that patient presented with a non-union and a broken plate.A revision surgery was performed on (b)(6) 2016 when the variable angle lcp (locking compression, curved condylar 8 hole) plate and 12 screws were removed and a retrograde femoral nail was implanted.The devices were easily removed without additional medical intervention and without fragments being generated.There was no delay in surgery and the patient was reported to be stable at the end of the procedure.This complaint involves one (1) device.Concomitant devices reported: screw (part # unknown, lot # unknown, quantity 12).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).One 4.5mm va lcp curved condylar plate (part # 02.124.409, lot # 9223281) was returned for investigation.The device was received broken into two pieces at the second combi-hole proximal to the head of the plate.There are numerous scratches and marks consistent with implantation and removal.A visual inspection of the fracture surfaces found no voids and or discolorations that might indicate a material issue.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.This complaint condition is confirmed.Seven (7) 5.0mm locking screws, three (3) 5.0mm cannulated locking screws, and two (2) 4.5 mm cortex screws were also returned without any complaint against them.A visual inspection of these concomitant devices found no issues that might have contributed to the complaint condition.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 product drawings were reviewed and 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.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.Replication of this complaint condition is not applicable since the device is already broken.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.During the investigation no manufacturing or product design issues or discrepancies were observed that may have contributed to the complaint condition.The design is determined to be adequate for its intended use when used and maintained as recommended.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).Updated concomitant devices reported.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

Concomitant devices reported: 5.0mm locking screws (part unknown, lot unknown, quantity 7), 5.0mm cannulated locking screws (part unknown, lot unknown, quantity 3), 4.5mm cortex screws (part unknown, lot unknown, quantity 2).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/8HOLE/195MM/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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5980795
• MDR Text Key: 55748218
• Report Number: 1000562954-2016-10188
• 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: 09/08/2016

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: 02.124.409S
• Device Lot Number: 9223281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2016
• Initial Date FDA Received: 09/27/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/12/2016; 11/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SCREW (PART # UNKNOWN, LOT # UNKNOWN, QTY 12
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR