MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH TI MATRIX SAGITTAL SPLIT PLATE STRAIGHT/4 HOLES/6MM BAR; BONE PLATE

Catalog Number 04.511.421

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Implant date is unknown.Explant date is unknown.Therapy date of concomitant device is unknown.Country state: (b)(6).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)(4) as follows: it was reported that the craniofacial surgery.Surgeon (b)(6) was preparing a pilot hole for screw implantation by drilling into the bone through the screw hole.The surgeon made multiple attempts, and changed the angle.This resulted in a widening of the screw hole in the plate.When the surgeon went to insert the screw the head went through the plate.The plate was removed and a new one used.2 minute delay to procedure.No ae to patient.Jnj rep was present at the procedure.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Manufacturing location: (b)(4).Release to warehouse date: july 18, 2017.No non-conformance reports 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.A product investigation was completed: upon visual inspection of the complaint device, three holes show visible signs of damaged, this thus confirming the complaint description.The damage can clearly be confirmed to be caused post manufacturing.Based on the information received, the surgeon has damaged the holes while pre-drilling.Concerning that the screw went with the head through the plate.No product fault could be detected.Due to intra-operative issues, the device was not implanted/explanted.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: TI MATRIX SAGITTAL SPLIT PLATE STRAIGHT/4 HOLES/6MM BAR
• Type of Device: BONE PLATE
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf ; SZ
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7050776
• MDR Text Key: 93500789
• Report Number: 8030965-2017-50067
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819357815
• UDI-Public: (01)07611819357815(10)L494524
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K083388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.511.421
• Device Lot Number: L494524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1