MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EFLEX ABLATOR PROBE INTEGRATED CABLE; ARTHROSCOPE

Catalog Number 72200683

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Arthralgia (2355)

Event Date 11/26/2014

Event Type  malfunction  

Manufacturer Narrative

Visual inspection and functional testing could not be performed because the device in question was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.A review of the device history records and quality records associated with this manufactured lot confirmed that one additional complaint of this nature has been filed and that no abnormalities were reported with this product during manufacture.No further investigation is warranted at this time.There are no indications that would suggest that the device did not meet product specifications upon release into distribution.

Event Description

It was reported that the plastic tip flaked off.The piece was removed and the surgery continued.It was also reported that a small amount of plastic tip fell off; the healthcare professional was confident that all debris was removed.A backup device was able to be used to complete the procedure.Patient was undergoing a right hip labral debridement and femoral head/neck osteochondropathy.Patient had longstanding right hip pain.Patient had an mri which showed a labral tear.Decision was made with patient and patient's parents to proceed with surgery for repair.There was no injury to the patient.No other complications were noted.

• Brand Name: EFLEX ABLATOR PROBE INTEGRATED CABLE
• 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: 5964355
• MDR Text Key: 55483023
• Report Number: 3003604053-2016-00067
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2015

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: 07/31/2016
• Device Catalogue Number: 72200683
• Device Lot Number: B66337
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2015
• Date Device Manufactured: 11/12/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16 YR