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

Model Number	ED7205786
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an acl reconstruction surgery, the saggital saw overheated; the handle was unable to be grabbed.A back-up device was available to complete the procedure without delay.Neither the patient nor the user suffer any injury.
Additional Manufacturer Narrative
The device was received for evaluation.There was a relationship found between the returned device and the reported incident.The device was returned to the supplier for 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 supplier reported the device was manufactured in 2004 and that the connector has corrosion and signs of arcing.Internal corrosion was found.The supplier reported the failure is most likely due to wear from use.Annual maintenance can prevent this.The complaint was verified.

• 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: 8620401
• Report Number: 1643264-2019-00357
• Device Sequence Number: 2017630
• Product Code: HAB
• UDI-Device Identifier: 03596010410719
• UDI-Public: 03596010410719
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/26/2019

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: ED7205786
• Device Catalogue Number: ED7205786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 68