MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 8.5MM X 110MM THREADED HIP CANNULA; ACCESSORIES, ARTHROSCOPIC

Catalog Number 72200436

Device Problems Component Falling (1105); Material Fragmentation (1261)

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

Event Type  malfunction  

Manufacturer Narrative

Date of the event is unknown at this time.(b)(6).Subject device(s) were returned for evaluation.Visual inspection confirms that pieces of the silicone material were torn from the device, but those pieces were not returned.A review of the device history records does not identify any discrepancies.A review of the device history report(s) did not identify any discrepancies.A review of the complaint history confirmed that no additional complaints were associated with the manufactured lot on file for the reported failure mode.Per results of the investigation, ¿no root cause could be found after evaluation¿.At this time, no further investigation will be implemented.(b)(4).

Event Description

During a hip arthroscopy, labral repair procedure utilizing the 8.5mm x 110mm threaded hip cannula system, it was reported that small pieces of the membrane have fallen off while inserting the device.The surgeon removed the debris with and alligator max grasper.Backup device was available and the procedure was completed successfully.It was reported that no pieces of membrane were left inside of the patient.(b)(4).

• Brand Name: 8.5MM X 110MM THREADED HIP CANNULA
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• 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: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4932937
• MDR Text Key: 22646603
• Report Number: 1219602-2015-00402
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: 72200436
• Device Lot Number: 50363011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2011
• 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