MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS POWER SMALL BATTERY HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	72204114
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device had not enough power.Procedure had to be completed with a competitor device.No significant delay or patient injury reported.
Additional Manufacturer Narrative
An evaluation was performed by the supplier and could confirm the customer complaint for the device had not enough power.A visual inspection was performed and showed the device failed for speed in reverse.When disassembled the motor showed to have hall errors and the lohet in the base also failed testing.This failure is caused by wear from use.No manufacturing related defects were observed.

• Brand Name: DYONICS POWER SMALL BATTERY HANDPIECE
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 7181795
• Report Number: 3003604053-2018-00008
• Device Sequence Number: 164141
• Product Code: HWE
• UDI-Device Identifier: 00885554033458
• UDI-Public: (01)00885554033458
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018

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 Model Number: 72204114
• Device Catalogue Number: 72204114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Initial Date Received by Manufacturer: 12/29/2017
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1