MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH MATRIX 1.4MM DRILL BIT J-LATCH/6MM STOP/44.5MM; DRILL, BONE, POWERED

Catalog Number 03.511.246

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

Additional product codes: erl and hbe.Complainant part is not expected to be returned for manufacturer review/investigation.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 synthes (b)(6) reports an event as follows: it was reported that on (b)(6) 2018, during the inter-molar distraction osteogenesis (imdo) procedure, two (2) trumatch mandible guide were heating up during pre-drilling.The cylinder and guides were heating up due to the drill.It was noted three (3) drill bits were touching the cylinder because of the angulation of the guide.There was no surgical delay.There was no adverse consequence to the patient and there was no issue with the plates or screws.Concomitant devices reported: mandible plate (part/lot unknown, quantity unknown), mandible screw (part/lot unknown, quantity unknown).This report is for a drill bit.This is report 3 of 3 for (b)(4).

• Brand Name: MATRIX 1.4MM DRILL BIT J-LATCH/6MM STOP/44.5MM
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8202882
• MDR Text Key: 131714318
• Report Number: 8030965-2018-59298
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 07611819376755
• UDI-Public: (01)07611819376755
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.511.246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1