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
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: DRILL, BONE, POWERED
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8202882
• Report Number: 8030965-2018-59298
• Device Sequence Number: 18882546
• Product Code: DZI
• UDI-Device Identifier: 07611819376755
• UDI-Public: (01)07611819376755
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K043310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.511.246
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 12/28/2018
• Patient Sequence Number: 1