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

Catalog Number 223146

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2017

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.One complaint device was received and evaluated by the npd engineer.Visual observation of the anchor under magnification revealed no structural anomalies that would have contributed to this failure.This was expected, as the complaint states that the returned device was unused and that the two complaint devices that pulled out were discarded and were not received by mitek.No complaint device is being returned for evaluation, and no lot number was supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system for the two complaint devices.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.Although we cannot discern a root cause, any of the aforementioned factors or a combination of factors could possibly lead to this failure.A review of the lot number 3787609 of the returned device indicates no complaints associated with this lot of (b)(4) devices released to distribution.At this point in time, based on the overall complaint rate, 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.

Event Description

This is report 1 of 2 for the same event.It was reported by the sales rep that two of his gryphon p br with permacord pulled out during a labrum repair surgical procedure.The sales rep stated that they opened three but did not use the third device.The case was completed with lupine.There were no patient consequences but a 30 minute delay was reported.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: GRYPHON P BR W PERMACORD
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 8271655
• MDR Text Key: 134874125
• Report Number: 1221934-2018-53358
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705024629
• UDI-Public: 10886705024629
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/10/2017

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: 06/30/2017
• Device Catalogue Number: 223146
• Device Lot Number: 3787609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2017
• Initial Date FDA Received: 01/23/2019
• Date Device Manufactured: 07/22/2014
• 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