MAUDE Adverse Event Report: DEPUY MITEK UNK LATARJET PRODUCT; LIGAMENT ANCHOR

Catalog Number UNK LATARJET PRODUCT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The lot expiration date and product code is not available currently.Associated medwatch: 1221934-2016-10405, 1221934-2016-10406, and 1221934-2016-10408.

Event Description

This report is being filed after the subsequent review of the following literature article: comparison of arthroscopic and open latarjet with a learning curve analysis.Authors: cunningham, g and et al knee surg sports traumatol arthrosc (2016) 24:540-545 doi 10.1007/s00167-015-3910-3.(b)(6).N= 2 non union issues, n= 3 migration issues, n= 3 infection issues, n= 1 re-operation.

Manufacturer Narrative

Mitek medical safety department discovered this published white paper detailing a historical event in which some mitek devices were implicated.It cannot be confirmed that this issue had been previously reported to mitek, so an adverse event report is being filed to document the experience described in the article.Further information from author suggests that the failure was caused by technique issues and not devices itself.At this point in time, no further action is warranted.However, this file will remains receptive to any potential forthcoming information received that is pertinent and germane to this issue.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: UNK LATARJET PRODUCT
• Type of Device: LIGAMENT ANCHOR
• 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: 5990061
• MDR Text Key: 56016146
• Report Number: 1221934-2016-10407
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK LATARJET PRODUCT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2016
• Date Manufacturer Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other