MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS RF-S WHIRLWIND 90 DEG; SAW, POWERED, AND ACCESSORIES

Catalog Number 72202139

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/10/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Visual inspection under magnification shows the screen has been completely detached from the tip.There is adhesive detached around the spacer in addition to discoloration from activation of the device.The cap has scratch marks present on the right side.The shaft is bent with damage to the black shrink tube down the right side of the shaft near the distal end of the wand which is consistent with excess force from either coming into contact with another object such as; bone, being used as a lever or for mechanical displacement of tissue.There are no manufacturing abnormalities visually observed with the returned wand.There are no indications that would suggest the wand did not meet product specifications upon release into distribution.There are no indications that would suggest the device did not meet product specifications upon release into distribution.

Event Description

While using whirlwind in the central compartment of the hip for treatment of the labrum, the metal plate became completely detached from the head of the probe.The whirlwind was used lightly against the bone.The piece was retrieved from the patient arthroscopically.No patient injury or other complications were reported.

• Brand Name: DYONICS RF-S WHIRLWIND 90 DEG
• Type of Device: SAW, POWERED, AND ACCESSORIES
• 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 ; 5123585706
• MDR Report Key: 5971491
• MDR Text Key: 55698570
• Report Number: 3003604053-2016-00082
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 72202139
• Device Lot Number: 1088536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1