MAUDE Adverse Event Report: LINVATEC CORPORATION D/B/A CONMED LINVATEC MICROPOWER ORAL MAX HIGH SPEED DRILL; SURGICAL DRILL

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2016

Event Type  malfunction  

Event Description

The drill's burr guard did not hold the burr.During the procedure, the doctor noted: "tissues were cleared between first and second molar region and preparation was made to perform osteotomy cuts.There was a technical dysfunction with the drill.A new drill had to be called for." there was no impact to the patient as there was a back-up sterile drill that was available for immediate use.Manufacturer response for micropower oral max high speed drill.Detachable lever, linvatec dental drill (per site reporter): repaired unit.

• Brand Name: MICROPOWER ORAL MAX HIGH SPEED DRILL
• Type of Device: SURGICAL DRILL
• Manufacturer (Section D): LINVATEC CORPORATION D/B/A CONMED LINVATEC; 11311 concept blvd; largo FL 33773
• MDR Report Key: 5750540
• MDR Text Key: 48215780
• Report Number: 5750540
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2016,06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2016
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/17/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR