MAUDE Adverse Event Report: DEPUY MITEK LLC US GRYPHON P BR DS ANCHOR W/OC; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 210813

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Not Applicable (3189)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Udi: (b)(4).

Event Description

It was reported that this was an abr (arthroscopic bankart repair) in the shoulder on (b)(6) 2020.The anchor was properly inserted into the lower glenoid.When the surgeon checked suture tension, the anchor came off.The replacing anchor was inserted into the same location, and the suture tension was checked again.Then, the same event took place.During the rest of the procedure, the surgeon used three more anchors without any further issue to complete the procedure.The procedure was delayed for 40 minutes.There was no harm to the patient.The devices were brand new and the first use when the issue occurred.Additional information provided by the affiliate reported the devices will not be returning for evaluation.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (6l44921), and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.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: GRYPHON P BR DS ANCHOR W/OC
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10707760
• MDR Text Key: 212178644
• Report Number: 1221934-2020-03094
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705001279
• UDI-Public: 10886705001279
• Combination Product (y/n): N
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

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: 10/31/2022
• Device Model Number: 210813
• Device Catalogue Number: 210813
• Device Lot Number: 6L44921
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 10/22/2020
• Supplement Dates FDA Received: 10/22/2020
• Patient Sequence Number: 1