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

Catalog Number 02.124.408S

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported a patient had failure osteosynthesis and secondary displacement.The 5 screws which were in the epiphyseal part of the plate slipped despite their locking with dynamometer.The patient had new surgery on (b)(6) 2014 and is reported to be in a good general state.The bone quality was reported to be ok and a communitive fracture was reported.An image reading of the 8 x-rays was conducted by a medical director from this manufacturer.The assessment reported: i reviewed the complaint description and x-ray images.I can confirm screw pull-out.I can¿t comment on the bone healing due to sub-optimal quality images.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional common device names: hrs, hwc.No nonconformance reports 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.The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: a manufacturing evaluation was completed: no visual defects related to the manufacturing process observed.All the product features relevant for the complaint issue were verified according to the drawing.Four holes were found conforming to specifications.Eight holes are visually damaged post production and some of the features cannot be measured.Moreover it was observed that the variable angle holes are damaged only on the deeper position of the threaded holes.The higher position is not visually damaged.The conclusion of the product investigation is that the complained part is conforming from a manufacturing perspective.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

Additional narrative: an investigation summary was performed.The investigation of the complaint articles has shown that: the complaint is confirmed as the screw back out is visible on the x-rays, but no product fault could be detected.The plate in question was manufactured in march 2014 with a lot size of 8 pieces and we are not aware of any other complaint for this article- and lot number.In this procedure the user has used regular locking screws (90° angle to the plate) with a plate using variable angle (va) va-lcp technology.The company advises the user in the surgical technique to use all available guiding tools to ensure nominal angle, i.E.90°.This is to guarantee proper locking of the lcp screw in the va-lcp hole of the plate and therefore ensure adequate construct stability.Non-va locking screws are in general compatible but not the first recommended option.In this case, when using non-va locking screws in va-lcp plates it is essential for construct stability to ensure nominal angle between screws and plate, as indicated in the surgical technique, 036.001.365.A visual inspection of the returned screws show partial circumferential deformation of thread.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/8HOLE/195MM/RT-STER
• Type of Device: CONDYLAR PLATE FIXATION IMPLANT
• 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: 4145636
• MDR Text Key: 4917127
• Report Number: 1000562954-2014-10190
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2024
• Device Catalogue Number: 02.124.408S
• Device Lot Number: 8881319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 85