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

Model Number WS-90

Device Problems Smoking (1585); Improper or Incorrect Procedure or Method (2017); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2016

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 242178518
• Report Number: 9681479-2017-00002
• Device Sequence Number: 1
• Product Code: KMW
• UDI-Device Identifier: J021300140001
• UDI-Public: J021300140001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080939
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WS-90
• Device Catalogue Number: 6514-7-200
• Device Lot Number: 01305
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1