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

Model Number 72204114

Device Problem Power Conditioning Problem (1474)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/29/2017

Event Type  malfunction  

Event 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.

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
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7181795
• MDR Text Key: 97062436
• Report Number: 3003604053-2018-00008
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00885554033458
• UDI-Public: (01)00885554033458
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/29/2017
• Initial Date FDA Received: 01/11/2018
• Supplement Dates Manufacturer Received: 02/27/2018
• Supplement Dates FDA Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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