MAUDE Adverse Event Report: DEPUY MITEK; ANCHOR IMPLANTS

Catalog Number UNK GRYPHON

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

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.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.O.Udi: unavailable.Depuy synthes has been informed that the catalog number and lot number is not available.

Event Description

The following issue was discovered via a published journal article by the mitek medical affairs officer.Authors: kenneth cutbush and kieran m.Hirpara.Reference: arthroscopic latarjet stabilization of the shoulder with capsulolabral repair address: brisbane hand and upper limb research institute and department of surgery, school of medicine, university of queensland, brisbane, australia.Email: research@upperlimb.Com.The procedure had been performed on 15 patients between january 2011 and august 2014 where all of the patients were males.One patient reported severe neural-type pain following the procedure, and on repeat arthroscopy the next day it was felt that the capsular repair was too tight.Release of the inferior-most anchor was performed with complete resolution of the pain immediately postoperatively.Presumably, the labral repair had been too tight and resulted in traction of the axillary nerve.

• Brand Name: NI
• Type of Device: ANCHOR IMPLANTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: joseph cipollo ; 325 paramount drive; raynham, MA 02767 ; 5089773839
• MDR Report Key: 5284547
• MDR Text Key: 33234032
• Report Number: 1221934-2015-10123
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• 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: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK GRYPHON
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 11/11/2015
• Date Manufacturer Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention