MAUDE Adverse Event Report: DEPUY MITEK MITEK CLEAR CANNULA SYSTEM 7.0 X 75MM - THREADED; ARTHROSCOPIC DRAINAGE CANNULA

Catalog Number 214116

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Depuy synthes has been informed that the lot number is not available.

Event Description

The sales rep reported via phone that a rubber dam pushed out of the seal on the 7.0x75mm fully threaded cannula during a rotator cuff procedure.Also a healix advance 4.5 anchor pulled out and broke in the same procedure.No debris in patient, no new bone hole was needed.The case was completed using another like anchor and a competitors cannula.There were no adverse patient consequences or delay.The devices will be returned for evaluation.

Manufacturer Narrative

The complaint device is not being returned, therefore unavailable for a physical evaluation and root cause for this failure cannot be determined.Furthermore, no lot number was supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.At this point, we cannot determine a root cause for this failure.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.Associated medwatch: 1221934-2017-10251.

• Brand Name: MITEK CLEAR CANNULA SYSTEM 7.0 X 75MM - THREADED
• Type of Device: ARTHROSCOPIC DRAINAGE CANNULA
• 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: 6525303
• MDR Text Key: 73796885
• Report Number: 1221934-2017-10173
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2017,04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 214116
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 03/28/2017
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: No
• 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