MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL PWR HIGH SPEED DRILL; SAW, POWERED, AND ACCESSORIES

Model Number	7209391S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device works intermittently and overheats.No patient or user injuries were reported.
Additional Manufacturer Narrative
The device was received and sent to the original equipment manufacturer (oem) for evaluation.There was a relationship found between the returned device and the reported incident.An evaluation was performed by the oem and no visual deficiencies were reported.Functional evaluation of the device by the oem found the unit got hot during testing.Troubleshooting by the oem found the motor to be bad and had been in the device since 2014.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.The complaint was confirmed and per the oem the root cause was determined to be wear from use.

• Brand Name: SVCE REPL PWR HIGH SPEED DRILL
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 7377497
• Report Number: 3003604053-2018-00052
• Device Sequence Number: 1392914
• Product Code: HAB
• UDI-Device Identifier: 03596010498014
• UDI-Public: (01)03596010498014
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2018

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: 7209391S
• Device Catalogue Number: 7209391S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1