MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VULCAN ABLATOR,90 DEG,INTEGRATED; ARTHROSCOPE

Catalog Number 7209659

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/01/2011

Event Type  Injury  

Manufacturer Narrative

Initial reporter zip code and telephone number: (b)(6).(b)(4).

Event Description

It was reported in arthroscopy: the journal of arthroscopic & related surgery [2014;30(8):957-963], "hip arthroscopy for femoroacetabular impingement: the changing nature and severity of associated complications over time", the tip of a flexible rf probe (vulcan ablator) broke.Journal article notes, "all broken surgical instruments were successfully removed, except a tip from a broken rf probe.However, this patient did not show any pain or mechanical symptoms attributable to the broken tip nor was the piece visible on radiography (p 1/4.045).".

Manufacturer Narrative

Device investigation narrative - visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product to look at.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.Our quality department will continue to monitor for trends.No further investigation is required.(b)(4).

• Brand Name: VULCAN ABLATOR,90 DEG,INTEGRATED
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: james gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5727291
• MDR Text Key: 47487116
• Report Number: 1219602-2016-00298
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K003893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7209659
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention