MAUDE Adverse Event Report: DEPUY MITEK GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY; MITEK ANCHOR IMPLANTS

Catalog Number 210820

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 07/17/2017

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Associated medwatch: 1221934-2017-10424.

Event Description

The affiliate reported via email after implantation of gryphon anchor code 210820 and after stitching the labrum, surgeon realized that sutures get out from the anchor.This was not the first case.In cases before surgeon thought that problem was with patient not following post-operative protocol, but then he realised the same situation with few patients.In this last particular case on (b)(6) 2017, surgeon found the problem during the surgery and he decided to make product complaint.Questions wont be answered until the complainant returns from vacation on this date: (b)(6) 2017.

Manufacturer Narrative

The complaint device is not available for a physical evaluation.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.Furthermore, the dhr review indicated that this batch of (b)(6) devices were processed without incident therefore, there is no evidence of manufacturing anomalies on the records reviewed.Review of the depuy synthes mitek complaints system revealed no other complaints for this lot of (b)(6) devices released to distribution.At this point in time, no corrective action is required, and no further action is warranted.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.Depuy 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Associated medwatch: 1221934-2017-10424, 1221934-2017-10425.

Event Description

The affiliate reported via email after implantation of gryphon anchor code 210820 and after stitching the labrum, surgeon realized that sutures get out from the anchor.This was not the first case.In cases before surgeon thought that problem was with patient not following post-operative protocol, but then he realised the same situation with few patients.In this last particular case on (b)(6) 2017, surgeon found the problem during the surgery and he decided to make product complaint.

• Brand Name: GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY
• Type of Device: MITEK ANCHOR 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: 6802019
• MDR Text Key: 83046642
• Report Number: 1221934-2017-10425
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140643
• 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: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 210820
• Device Lot Number: L328699
• 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: 07/19/2017
• Initial Date Manufacturer Received: 07/19/2017
• Initial Date FDA Received: 08/17/2017
• Supplement Dates Manufacturer Received: 09/11/2017
• Supplement Dates FDA Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2017
• 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