MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS RF-S WHIRLWIND 90 DEG; ARTHROSCOPE

Catalog Number 72202139

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/17/2014

Event Type  malfunction  

Manufacturer Narrative

A visual inspection under magnification showed minimal electrode screen wear with blood and tissue present.Physical evidence in the form of a deformed electrode screen adjacent to the missing ball location and a fracture surface where the ball was once located indicate the ball was dislodged due mechanical force.The signal cable was observed to be cut, presumably to prevent reuse.No physical manufacturing abnormalities were observed.The suction line was tested and performed as intended; however, a function plasma test of the electrode was not conducted since the signal cable had been cut.The root cause for this event indicates dissociation of the electrode ball due to mechanical force, most likely user induced.There are no findings that would indicate the wand did not meet product specifications when released for distribution.There are no indications that would suggest the device did not meet product specifications upon release into distribution.

Event Description

One of the small metal electrodes broke off the tip of the probe.It was retrieved with a grasper.No patient injury or other complications were reported.

• Brand Name: DYONICS RF-S WHIRLWIND 90 DEG
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5964338
• MDR Text Key: 55430923
• Report Number: 3003604053-2016-00065
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2016
• Device Catalogue Number: 72202139
• Device Lot Number: 1052630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1