MAUDE Adverse Event Report: DEPUY MITEK LLC US GRYPHON PEEK W/PROKNOT; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number 210821

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Udi: (b)(4).

Event Description

It was reported by sales rep via complaint submission tool that during an unknown procedure, while using a gryphon peek anchor w/ proknot technology, the anchor was not connected with shaft very closely, when they knoted the suture, the anchor was pulled out.Another device was used to complete the surgery.No surgical delay or patient consequence reported.No additional information could be provided.

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: d10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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: according to the information provided, it was reported by sales rep via complaint submission tool that during an unknown procedure, while using a gryphon peek anchor w/ proknot technology, the anchor was not connected with shaft very closely, when they knoted the suture, the anchor was pulled out.The complaint device was received and evaluated.Visual observations confirm that the anchor was detached from the driver shaft but is held in place by suture.The compliant can be confirmed.The possible root cause for the reported failure can be associated with incomplete insertion into the bone hole, using instruments not indicated to be used with the anchor, poor bone quality and applying excess force on suture during tensioning.Although we cannot discern a root cause, any of the aforementioned factors or a combination of factors could possibly lead to this failure.A manufacturing record evaluation was performed for the finished device [l717700] number, 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 PEEK W/PROKNOT
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10320687
• MDR Text Key: 200617728
• Report Number: 1221934-2020-01906
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705024049
• UDI-Public: 10886705024049
• Combination Product (y/n): N
• PMA/PMN Number: K140643
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2020

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: 01/31/2021
• Device Model Number: 210821
• Device Catalogue Number: 210821
• Device Lot Number: L717700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 08/03/2020; 08/21/2020
• Supplement Dates FDA Received: 08/04/2020; 08/21/2020
• Patient Sequence Number: 1