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

Catalog Number 210821

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/02/2015

Event Type  Injury  

Manufacturer Narrative

The complaint device is not available for a physical evaluation and therefore a root cause for this failure cannot be discerned.Typically, anchor pull outs are 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.It is a possibility that any of the aforementioned factors or a combination of factors could have possibly lead to this failure.A batch record review has been conducted and the results indicate that this batch of product was processed without any incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.From the complaint history, it seems that this failure is an anomaly and an isolated incident.At this point in time, 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.

Event Description

The sales rep reported that during a shoulder procedure their gryphon proknot peek shoulder during suture passing, the anchor did not hold and pulled out.The sales rep stated that the bone quality was average.The sales rep reported that the surgeon completed the procedure by drilling a new hole and using a competitor's device with no patient consequences but there was a six minute delay.The sales rep stated that the surgeon left the other bone hole empty.The sales rep stated that the device was discarded.

• Brand Name: GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY
• Type of Device: ANCHOR IMPLANTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; quality department; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; na; raynham MA 02767
• Manufacturer Contact: siri belur ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 5111471
• MDR Text Key: 27053374
• Report Number: 1221934-2015-00991
• 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,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 210821
• Device Lot Number: 3810443
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/02/2015
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2015
• Date Manufacturer Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2014
• 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