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	07/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device had a short.
Additional Manufacturer Narrative
The device was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed and corroded sockets and damaged socket housing were observed.A functional test revealed the device runs in forward and reverse from both the hand piece trigger and the footswitch pedals.Current draw was under 700ma.The reported malfunction was not observed during functional evaluation.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 not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the functional testing process.

• 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: 7763580
• Report Number: 1643264-2018-00591
• Device Sequence Number: 1280620
• 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: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2018

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: 09/13/2018
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1