MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS POWER II CONTROL SYSTEM; ARTHROSCOPE

Catalog Number 72200873

Device Problem Insufficient Information (3190)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 04/14/2015

Event Type  Injury  

Manufacturer Narrative

Initial reporter: foreign postal code (b)(6).Subject device was returned for evaluation.A visual inspection was performed on the exterior and interior of product and no damage was found.Complaint of skin burn could not be reproduced.No faults or errors occurred during functional testing and no damage occurred to test blades used during functional testing.All functions perform as expected.No issues were identified.At this time, no further investigation will be performed.(b)(4).

Event Description

During an unknown procedure utilizing the dyonics power ii control system, it was reported that surgery was going as planned until patient's leg began to shake after blade was inserted.It was reported that the surgeon suspected the patient's reaction was due to insufficient anesthesia.It was reported that the anesthesia was strengthened and the procedure continued.It was reported that a skin burn was identified post procedure.It was reported that the wound was cleaned and bandaged.It was reported that, upon inspection of the burn the following day, the wound was discovered to be more serious.It was reported that the patient underwent a skin graft surgery.It is unknown whether a back-up device was available.(b)(4).

• Brand Name: DYONICS POWER II CONTROL SYSTEM
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5141222
• MDR Text Key: 27964434
• Report Number: 1643264-2015-00160
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K062849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200873
• Device Lot Number: AAX15918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention