MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS POWER DRILL; SAW, POWERED, AND ACCESSORIES

Model Number	7205785
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device shorted.No delay or patient injures were reported.
Additional Manufacturer Narrative
Device evaluation: the device was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and corrosion was observed on the cable connector pins and sockets.A prong was missing in the cable connector.A functional evaluation revealed the motor would not run.The complaint of shorting was confirmed and the root cause was associated with electrical component failure.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.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include inadvertent damage to the cable.

• Brand Name: DYONICS POWER DRILL
• 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: 7369755
• Report Number: 3003604053-2018-00050
• Device Sequence Number: 1446323
• Product Code: HAB
• UDI-Device Identifier: 03596010410702
• UDI-Public: (01)03596010410702
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2018

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: 7205785
• Device Catalogue Number: 7205785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Initial Date Received by Manufacturer: 03/01/2018
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 03/26/2018
• Supplement Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1