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 Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the plate broke after four months.Patient had to have a revision open reduction internal fixation (orif) and was implanted with a less invasive stabilization system (liss) plate.There was no report of a surgical delay.This report is 1 of 1 for complaint (b)(4).

Event Description

Additional information from synthes (b)(4) regarding the event in (b)(6) was reported as follows: the revision was completed to the satisfaction of the surgeon.The patient is recovering well.The patient was weight bearing and the doctor does not suspect there was any fall which lead to the plate breaking.He described the patient as being very compliant.No screws had broken and there appeared to be callus formation around the fracture site indicating that the fracture was healing well.This was not treated as a non-union.

Event Description

Device report from synthes (b)(4) reported an event in (b)(6).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional product code for this report includes; hrs and hwc.The investigation could not be completed; no conclusion could be drawn, product is entering the complaint system.A review of the device history records was performed and no complaint related issues were found.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Event occurred in (b)(6) as initially reported, not (b)(6).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: event occurred in (b)(6) , not (b)(6) as previously reported.Additional information regarding the patient and surgical outcome was added.A manufacturing evaluation was performed for the subject device.The subject plate was received in a broken condition as described in the complaint.The plate 02.124.410 was implanted on the (b)(6) 2014 for the fixation of a periprosthetic femur fracture on the right side.According to the device report the breakage of the plate was observed on the (b)(6) 2014.The revision surgery was conducted on (b)(6) 2014 with the removal of the implants and re-osteosynthesis by means of a liss plate.The plate was made of material (b)(4)(stainless steel).The examination of the raw-material inspection sheet of the supplier and the manufacturing documents of the producer showed no deviation in relation to the chemical composition, microstructure and mechanical properties.The material of the plate is in compliance with the international standards iso 5832-1 and astm f138 for implants made of material (b)(4).The dimensions of the investigated plate were checked using a digital sliding caliper and found to be in compliance with the technical drawings of the producer and ao/asif specifications.The width of the plate* was 17.75 mm and the thickness was 5.67 mm.The measurements were taken close to the fracture site.The plate fracture surfaces underwent macroscopic and sem examination.Based on the topography of the fracture surfaces, it can be concluded that the plate was subjected to low dynamic bending loads (one sided).Constantly alternating bending loads i load cycles (during walking) led to the fatigue of the material, then to a first crack and finally to the overload respectively to the fatigue fracture of the plate.The plate could not resist the applied force which finally led to the material overload i fatigue failure.A failure resulting from either a material defect or the manufacturing process can be excluded.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 CH68 05; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4297551
• MDR Text Key: 5269201
• Report Number: 1000562954-2014-10213
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• 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: 7867156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention