MAUDE Adverse Event Report: DEPUY MITEK LLC US CLEARCANNULA-THREADED 8.5MMX75MM 5PK -ST; ARTHROSCOPIC DRAINAGE CANNULA

Catalog Number 214120

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).

Event Description

It was reported by the affiliate via email that when the surgeon placed the yellow 8.5mm clear cannula threaded as per standard procedure on the metal obturator and over the switching stick.On passing a 5.5mm burr as standard through the portal (cannula) part of the triple seal dam became unattached from the underside of the top part of the cannula and was, therefore, lose within the patient.The plastic portion (as shown in the photo) was removed from the shoulder using a tissue grasper.The issue was found at the end of the procedure, so the surgeon then also removed the cannula.There was no patient harm or surgical delay reported.The procedure involved is a shoulder scope.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H6: investigation summary: the complaint device is not being returned, it was discarded by the customer; therefore, it is unavailable for a physical evaluation.However, a photo was available for further evaluation.Upon visual inspection of the photograph, it is observed that there is a small fragment of the triple seal dam, hence confirming the complaint condition.The possible root cause for the reported failure could be attributed to repeated use of the device.A manufacturing record evaluation was performed for the finished device lot number 1703057, and no non-conformances were identified.At this point, 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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CLEARCANNULA-THREADED 8.5MMX75MM 5PK -ST
• Type of Device: ARTHROSCOPIC DRAINAGE CANNULA
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8784787
• MDR Text Key: 150848907
• Report Number: 1221934-2019-57621
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10886705003617
• UDI-Public: 10886705003617
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 214120
• Device Lot Number: 1703057
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2019
• Patient Sequence Number: 1