MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.406

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during a revision surgery for a broken screw head, another fragment broke off of the screw in the extraction bolt.The head of the screw was thrown away during surgery.The broken screw fragment remains implanted in the femur shaft.The variable angle locking 6 hole compression plate was intact.Screws were explanted and it was confirmed the other screws removed successfully; only one screw was broken.The patient was re-plated with an 8-hole lcp congular plate and screws.It was also reported that a hollow reamer broke off while reaming during the revision procedure, but all parts were retrieved.The surgery was completed successfully.The procedure was extended by fifteen minutes due to the complained events.Initial implant surgery took place in 2013; the exact date was not provided.The condition of the patient after surgery was reported as unknown.This is report 4 of 5 for (b)(4).

Manufacturer Narrative

Additional product codes: hrs, hwc.Implant date: unknown date in 2013.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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

Device was used for treatment, not diagnosis.Additional narrative: the visual inspection of the returned device performed as part of the product investigation reported the device has a significant number of scratches and deformation from implantation and explantation.The device was manufactured in 3/2012 and is over 2 years old.The part 02.124.406, lot #7805700 4.5mm va-lcp curved condylar plate was received intact.The 02.124.406 4.5mm va-lcp curved condylar plate is routinely used in the 4.5mm va-lcp curved condylar plate system (technique guide j10446-d).The 309.480 spare reamer tube is intended for use in the screw removal set (technique guide j8569-c).The 02.214.406 curved condylar plate and associated screw construct was explanted due to a failed screw which resulted in a failed fusion.No screws were returned.The plate was returned and has a significant number of scratches and deformation from implantation and explantation.Drawing number se_366691 rev.G was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.No product issue was identified in the complaint description or noted upon examination.The returned reamer tube shows moderate to heavy wear and is missing a triangular portion of the tip of the device in addition to missing several teeth.The device was returned and reported to have broken when being used to explant a 4.5mm va-lcp curved condylar plate and its associated screws.This condition is confirmed; the device has a triangular gauge in the tip which runs one centimeter down the length of the device.This is likely due to a collision with a substance harder than bone during the procedure such as either the screw or the plate.Drawing number se_037141 rev.A was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.No product issue was identified in the complaint or noted upon examination of the returned 02.214.406 plate.The issue noted with the 309.480 reamer was most likely due to a collision with another device, one of the screws, and led to the complaint condition noted.This complaint is not a result of any design related deficiency.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/6 HOLE/159MM/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: 3809218
• MDR Text Key: 11959563
• Report Number: 1000562954-2014-10080
• 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: 04/22/2014

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.406
• Device Lot Number: 7805700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2014
• Initial Date FDA Received: 05/13/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/02/2014; 11/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention