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 Patient Involvement (2645)
Date of Event	03/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported a short circuit on the device.No patient involved as the failure was found before the surgery.There were no overheating, sparking , error message or smoke reported.
Additional Manufacturer Narrative
Additional information was received stating that the event did not result in an overheating, sparking, error message or smoking of the device.Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

• 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: 8520551
• Report Number: 1643264-2019-00278
• Device Sequence Number: 1885142
• Product Code: HAB
• UDI-Device Identifier: 03596010251800
• UDI-Public: 03596010251800
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 05/02/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1