MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS WIRE DRVR SM BAT HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	72204127
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device presented a false channel.No patient injury reported.There was not backup available.
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product to look at.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.Our quality department will continue to monitor for trends.
Additional Manufacturer Narrative
An evaluation was performed by the supplier and could confirm the customer complaint for the device presented a false channel.Functional inspection was performed and showed the device failed testing.The wire drive split collet was worn.This failure is due to wear from use.This device has been out in the field since 2015.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: DYONICS WIRE DRVR SM BAT 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: 7512220
• Report Number: 3003604053-2018-00070
• Device Sequence Number: 13893157
• Product Code: HWE
• UDI-Device Identifier: 00885554033588
• UDI-Public: (01)00885554033588
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2018

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: 72204127
• Device Catalogue Number: 72204127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Initial Date Received by Manufacturer: 04/16/2018
• Supplement Date Received by Manufacturer: 06/07/2018; 09/04/2018
• Initial Report FDA Received Date: 05/14/2018
• Supplement Report FDA Received Date: 06/13/2018; 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1