MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.85MM TI MATRIX SCREW SELF-TAPPING/4MM; BONE PLATE

Catalog Number 04.511.204.04C

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 that the mandible guide holes were unable to be reached.The surgeon did not pre drill holes, the left guide original cut was incorrect and the plates were not placed in the correct position.This led to the proper occlusion not being achieved and the cuts and plate positions had to be redone three (3) times before the screws held the osteotomy in place.The surgeon was unable to accommodate the drill being able to fit in the mouth, had trouble seating the guides, there were not enough images to support the guide fixation, the screws failed and pulled out and the braces started coming off.The screws failed due to the surgeon putting the plate in the incorrect position.This was the surgeon¿s first planning with the mandible guides.The planner should have been prompting the surgeon about what he was wanting to achieve/where he would be able to drill.The surgeon did not know how hard the guides were to drill through until he saw them.The surgeon approved the designs; however he wasn't aware how hard it would be to get access for the drill until he saw them on the patient.The guides had been planned using a 90 degree drill however, the hospital does not have a 90 degree drill to use.The surgeon was unable to check the guides before the procedure because they have to be sterile for the patient.The post op x-rays of the patient looked good and the surgeon is ok with the outcome.Concomitant devices: unknown guide (part# unknown, lot# unknown, quantity unknown), unknown matrixorthognathic plate (part# unknown, lot# unknown, quantity unknown).This report is for one (1) 1.85mm ti matrix screw self-tapping/4mm.This is report 2 of 3 for (b)(4).

Event Description

Concomitant devices reported: trumatch midface/mandible ti 3d printed guide/ mandible (part# sd980.017, lot# unknown, quantity 1); matrixorthognathic plate (part# unknown, lot# unknown, quantity unknown).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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

This is report 2 of 4 for (b)(4).

• Brand Name: 1.85MM TI MATRIX SCREW SELF-TAPPING/4MM
• Type of Device: BONE PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10239409
• MDR Text Key: 197972067
• Report Number: 8030965-2020-04670
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: K083388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.511.204.04C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2020
• Patient Sequence Number: 1
• Treatment: TRUMATCH MIDFACE/MANDIBLE TI 3D PRINTED GUIDE; UNK - GUIDES/SLEEVES/AIMING; UNK - PLATES: MATRIXORTHOGNATHIC; UNK - PLATES: MATRIXORTHOGNATHIC
• Patient Age: 14 YR