MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MINI MOTOR DRIVE UNIT EP-1; SAW, POWERED, AND ACCESSORIES

Catalog Number	7205357
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a procedure, the shiver razor could not be used for tissue joint removal since it the motor in the hand piece failed as it was indicated in the console.Procedure was completed with a competitor device.No significant delay was reported and no patient injuries were reported.
Additional Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation, thus functional testing could not be performed.There was a relationship found between the subject device and the reported incident.A visual inspection of the customer provided images showed a hand piece motor fault error.The complaint was confirmed and the root cause has been associated with mechanical component failure.Factors that could have contributed to the reported event include corrosion in the gearbox/motor assembly from cleaning and sterilization methods and the chemicals involved over a period of time or one or more of the motor phases shorting out.

• Brand Name: MINI MOTOR DRIVE UNIT EP-1
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 8588399
• Report Number: 1643264-2019-00322
• Device Sequence Number: 2065811
• Product Code: HAB
• UDI-Device Identifier: 03596010251800
• UDI-Public: 03596010251800
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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 Catalogue Number: 7205357
• Device Lot Number: TS17740
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1