MAUDE Adverse Event Report: DEPUY MITEK CLEAR CANNULA SYSTEM 8.5 X 75 MM ¿ THREADED; MITEK ARTHROSCOPIC INSTRUMENTS

Catalog Number 214120

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 07/25/2017

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The device was received and visually inspected.Visual inspection revealed that one of the silicone dams, the dam with a hole located on the top, was missing.The missing dam was not returned for evaluation.The compliant can be confirmed.This is an indication of excess force being applied to pass instruments through the cannula.No information on what instruments were passed through the cannula was available.This failure can be attributed to user technique.A dhr review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.A review into the depuy synthes mitek complaints system revealed no other complaint for this lots of devices that were released to distribution.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).

Event Description

The sales rep reported via phone that the dam pushed through the customer's fully threaded cannula and was leaking during a shoulder scope.The case was completed with another like device.There were no patient consequences or delays.The sales rep was not present during the case and could not provide any more details.The device is being returned.Additional information received via email from affiliate on 08-16-17.The dam was leaking during a shoulder scope.It was triggered and noticed when water was squirting out of the cannula.There was no surgical delay.The leakage occurred in the cannula.The procedure was able to be completed by opening an additional cannula.No patient impact.

• Brand Name: CLEAR CANNULA SYSTEM 8.5 X 75 MM ¿ THREADED
• Type of Device: MITEK ARTHROSCOPIC INSTRUMENTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 6815074
• MDR Text Key: 83686355
• Report Number: 1221934-2017-10449
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 214120
• Device Lot Number: 1610032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2017
• Date Manufacturer Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2017
• 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