MAUDE Adverse Event Report: DEPUY MITEK MENISCAL APPLIER, OMNISPAN; MITEK MENISCAL INSTRUMENTS

Catalog Number 228143

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Code Available (3191)

Event Date 10/18/2016

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Associated medwatch: 1221934-2016-10492, 1221934-2016-10493.(b)(4).Depuy synthes has been informed that the lot number is not available.

Event Description

Attempt of the inner meniscus fixation, first backstop triggerable, second backstop not triggerable.The same problem occurred with the two devices, both used in one procedure.Meniscus could not be refixated fully only partially.Additional information received via email from the affiliate on (b)(6) 2016.The meniscus had to be resected.The first implant was left behind the capsule.New location was used, did not use the same.

Manufacturer Narrative

The complaint device was received and inspected visually and functionally.Visual observation reveals no anomalies on the device.When tested for its functionality, both triggers functioned properly when pulled on their own without a needle attached to the device.A 27-degree needle was loaded onto the applier and both implants were deployed successfully.The applier works as intended and we cannot confirm the reported complaint.Furthermore, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.At this point in time, no corrective action is required and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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.

• Brand Name: MENISCAL APPLIER, OMNISPAN
• Type of Device: MITEK MENISCAL 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: 6111896
• MDR Text Key: 60281427
• Report Number: 1221934-2016-10494
• Device Sequence Number: 1
• Product Code: GEF
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 228143
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2016
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other