MAUDE Adverse Event Report: DEPUY MITEK MITEK CLEAR CANNULA SYSTEM 7.0 X 75 MM - 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.The complaint device is not being returned; it was discarded by the customer and therefore is unavailable for a physical evaluation.A device history record 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.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of 5,500 devices that were released to distribution.We cannot discern a root cause for the reported failure mode.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.(b)(4).Device not returned.

Event Description

The sales rep reported via phone that the rubber portion of the seal at the top was pushed into the customer's 7.0x75mm fully threaded cannula during a rotator cuff procedure.The rubber portion fell into device only, nothing in patient.There were no adverse patient consequences or delay.The case was completed with another like device.The sales rep stated the device was discarded by the customer.

• Brand Name: MITEK CLEAR CANNULA SYSTEM 7.0 X 75 MM - 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: 6526871
• MDR Text Key: 73907972
• Report Number: 1221934-2017-10174
• 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: 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 Expiration Date: 12/31/2021
• Device Catalogue Number: 214116
• Device Lot Number: 1610031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 1 MO
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 03/28/2017
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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