MAUDE Adverse Event Report: SYNTHES SELZACH TI MATRIXMANDIBLE 2X2H DCP PL 1.25MM THICK-STERILE; BONE PLATE

Catalog Number 04.503.710S

Device Problems Bent (1059); Fitting Problem (2183)

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

Event Date 02/03/2017

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient information is unknown.No information provided by hospital.(b)(4).Device inserted and removed during same surgery; therefore, no implant and explant date is available since patient was not closed up with device.(b)(6).Device history review for the sterilization procedure only: manufacturing location: (b)(4).Supplier: (b)(4).Manufacturing date: 27.Jan 2016.Expiry date: 01.Jan 2026.No nonconformances were 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.Non-sterile 04.503.710 / 9976330 was manufactured in us, monument.Part #: 04.503.710, lot #: 9976330 (non-sterile) - ti matrixmandible 2x2h dcp pl 1.25mm thick.Quantity 64.Reviewed in-process meet acceptance criteria of inspection sheet.Components: raw material lot no: 9913659 reviewed.No nonconformances were 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.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 europe reports an event in (b)(6) as follows: it was reported that plate was used for orif (open reduction internal fixation) of the left ramus of mandible oblique fracture on (b)(6) 2017.The plate was bent very slightly, and applied vertically against the ramus of mandible.The first screw was inserted to nearly above to the fracture line, and the second screw was inserted to nearly below the fracture line.When the third screw was about to be inserted, the surgeon noticed that the first screw disappeared from the sight.It was found that the screw head passed through the plate¿s screw hole.Therefore, the surgeon decided to use another back up plate instead.The screw which firstly used and passed through the screw hole was used again and this time, all three screws were succeeded to lock the plate.The surgeon commented that the screw was inserted vertically against the plate, and the plate was not bent too much to cause the screw hole to become wider.The plate was bent by the surgeon, but the surgeon commented that he/she didn¿t bent it too much.The surgery was delayed for 20 minutes.There are no fragments remained in the patient¿s body.There was no patient harm, procedure was successfully completed with no other medical intervention.There was a surgical prolongation of 20 minutes reported.Concomitant device: 2 qty unknown screws.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A manufacturing investigation was performed for the subject device (brand name ti matrixmandible 2x2h dcp pl 1.25mm thick-sterile, part number 04.503.710s, lot number 9805769).The subject device was received loose in a bag and is laser etched with part number 04.503.710 lot# 9976330.A visual inspection of the plate shows the part is slightly bent/deformed with marks and scratches present on the top surface of the plate.The top surfaces of holes 2 and 3 show heavy marks and gouges in the countersink and thread damage.As previously reported, the device history record review showed that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Lot 9976330 was manufactured in january 2016, 64 parts according to synthes specifications.All devices were sold meanwhile and we are not aware of any quality issues associated with this part/lot number.This lot met all dimensional and visual criteria at the time of release for shipment with no issues documented that would contribute to the complaint condition, it has been concluded any damage, twisted, or out of specification condition due to damage occurred after the product left manufacturing.Based on these findings and without having the reported unknown screws the complaint condition is confirmed but the root cause of this complaint is undetermined.No indication for product related issue was found.(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 MATRIXMANDIBLE 2X2H DCP PL 1.25MM THICK-STERILE
• Type of Device: BONE PLATE
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6374929
• MDR Text Key: 68979268
• Report Number: 3000270450-2017-10067
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.710S
• Device Lot Number: 9805769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: QTY 2 FOR UNKNOWN SCREWS