MAUDE Adverse Event Report: W&H DENTALWERK BUERMOOS GMBH RIGHT ANGLED SCREWDRIVER; WS-90

Model Number	WS-90
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the procedure, the screwdriver became jammed and got hot.Obviously, the speed limitation of 10,000 rpm was not adhered to.The ws-90 itself is marked with the information to use at a maximum motor speed of 10,000 rpm.No injuries occured.All of the treatments were completed successfully without a delay.No indication could be found in the investigation of any material or manufacturing related issue.The screwdriver functions as intended and according to its specifications.The device is already marked with the information to use only at a maximum speed of 10,000 rpm.
Event or Problem Description
Event description by initial reporter (b)(4): it was reported by a company representative that during a bsso procedure, the right angle screwdriver became jammed and started smoking.The device was used at a speed of 50,000 rpm's despite the fact that the ifu states (and the ras itself is marked with) the information to use at a maximum motor speed of 10,000 rpm's.There were no adverse events reported and the surgery was completed successfully without delay with a back up drill.

• Brand Name: RIGHT ANGLED SCREWDRIVER
• Common Device Name: WS-90
• Manufacturer (Section D): W&H DENTALWERK BUERMOOS GMBH; ignaz-flaser-strasse 53; buermoos, 5111 ; AU 5111
• Manufacturer Contact: anja lindner ; ignaz-glaser-strasse 53; buermoos, salzburg 5111 ; AU 5111
• MDR Report Key: 6989655
• Report Number: 9681479-2017-00002
• Device Sequence Number: 4352400
• Product Code: KMW
• UDI-Device Identifier: J021300140001
• UDI-Public: J021300140001
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K080939
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2016

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 Model Number: WS-90
• Device Catalogue Number: 6514-7-200
• Device Lot Number: 01305
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2017
• Supplement Report FDA Received Date: 10/31/2017
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown