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

Model Number	7209391
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the dyonics unit overheated.There was no significant delay or patient injury reported.
Additional Manufacturer Narrative
The device was sent to the oem (original equipment manufacturer) for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and there was corrosion observed when it was disassembled.A functional evaluation confirmed the problem of overheating.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 verified and per the oem the root cause is likely due to wear.

• 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: 7228508
• Report Number: 1643264-2018-00088
• Device Sequence Number: 1475505
• Product Code: HAB
• UDI-Device Identifier: 03596010466167
• UDI-Public: (01)03596010466167
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2018

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: 7209391
• Device Catalogue Number: 7209391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Initial Date Received by Manufacturer: 01/03/2018
• Supplement Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 01/30/2018
• Supplement Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1