MAUDE Adverse Event Report: DEPUY MITEK UNKNOWN ANCHOR; UNKNOWN MITEK IMPLANTS

Catalog Number UNK BONE ANCHOR

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

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.Two patients had a re-surgery to remove anchor fragments.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.The author has been contacted to obtain further information but no response was received.At this point in time, no further action is warranted.However, this file will remain 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.Udi - unavailable.The product details are not available.Associated medwatch: 1221934-2017-10142.

Event Description

This report is being filed after the subsequent review of the following article: arthroscopic suture-bridge repair for small to medium size supraspinatus tear: healing rate and retear pattern.Authors: neyton lionel m.D.And "et al" arthroscopy: the journal of arthroscopic and related surgery, vol 29, no 1 (january), 2013: pp 10-17 shoulder unit and radiology unit.(b)(6).N=2 2 patients needed anchor fragments removed.

• Brand Name: UNKNOWN ANCHOR
• Type of Device: UNKNOWN MITEK IMPLANTS
• 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: 6474438
• MDR Text Key: 72194378
• Report Number: 1221934-2017-10143
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK BONE ANCHOR
• 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: 03/09/2017
• Initial Date Manufacturer Received: 03/09/2017
• Initial Date FDA Received: 04/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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