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

Model Number	7205786
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that dyonics power sagittal saw was not operating and then the hand piece started to overheat.No patient injury was reported.
Additional Manufacturer Narrative
The device was received and sent to the oem (original equipment manufacturer) 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.A functional evaluation was performed by the oem and it was reported that the handpiece was not running and overheated due to a seized motor.The complaint was verified and the root cause was determined to be an electrical 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.

• Brand Name: DYONICS POWER SAGITTAL SAW
• 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: 7072577
• Report Number: 1643264-2017-01801
• Device Sequence Number: 1133097
• Product Code: HAB
• UDI-Device Identifier: 03596010410719
• UDI-Public: (01)03596010410719
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2018

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: No Information
• Device Model Number: 7205786
• Device Catalogue Number: 7205786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1