MAUDE Adverse Event Report: SYNTHES MEZZOVICO TI MATRIX CURVED SAGITTAL SPLIT PLATE/6 HOLES/6MM BAR; BONE PLATE

Catalog Number 04.511.401

Device Problems Failure To Adhere Or Bond (1031); Failure to Align (2522); Device Operates Differently Than Expected (2913)

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

Event Date 05/18/2015

Event Type  malfunction  

Event Description

Device report from synthes eu reports an event in (b)(6) as follows: an inferior plate hole was slightly contoured to lower border of mandible, which resulted in the screw passing straight through the plate and screw head did not engaging with plate.The surgery was prolonged about 15 minutes.The plate was completely removed and a standard 4-hole plate was used instead.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Reported device not implanted / explanted.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Lot number identified as 9148209.A device history record review was performed for the subject device lot number 9148209.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.A manufacturing investigation was performed for the subject device (part number 04.511.401, ti matrix curved sagittal split plate/6 holes/6mm bar, lot 9148209).The subject device was received was received with five of the six holes of the plate more or less damaged.One hole is badly damaged and has a large burr on the lower side.The relevant dimensions of the holes cannot be verified anymore due to the damage.In five of the six holes the received screw still stays in position.In the sixth hole, the one with the heaviest damage, the screw falls through as complained.At all damages the anodized layer is worn out, which is clear indication that the damages were caused post-manufacturing by an excessive metallic contact, either with the drill bit or the screw.Especially for the most damaged hole it can be concluded that the damage and the burr was caused by an heavy contact with a drill bit as the damage is too heavy to be only caused with a screw contact.In addition, it was observed that the damage is mainly on one side of the hole, which indicates an excessive insertion angle.The complaint is confirmed as the screw passes through one hole as complained, but the issue is not manufacturing related as the damages to the plate were clearly caused post-manufacturing.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI MATRIX CURVED SAGITTAL SPLIT PLATE/6 HOLES/6MM BAR
• Type of Device: BONE PLATE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico PA 19380 CH6; SZ 19380 CH68
• 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: 4827399
• MDR Text Key: 5913159
• Report Number: 2520274-2015-14332
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK083388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.511.401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27 YR