MAUDE Adverse Event Report: DEPUY MITEK LLC US GII QA+ #2 ETH CP-2 *EA; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 212034

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2013

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.Evaluation statement: the complaint device is not being returned, therefore is unavailable for a physical evaluation.A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without 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 of any kind for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.However, 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.(b)(4).This report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

Event Description

It was reported by the sales rep that during an open bankart procedure that the sutures came right out on the customer's g ii quick anchors plus 2 excel ethibond.The sales rep reported that once all 3 anchors were inserted in the bone hole and secured, the surgeon then proceed to tie the sutures and on all 3 anchors the sutures just came right out.The 3 anchors were left in the bone holes and the surgeon was satisfied with their placement.The surgeon completed the procedure by drilling 3 new bone holes and inserting another 3 super quick anchors (product code (b)(4)) with no patient consequences and a 20 min delay.Please see also medwatch report 1221934-2018-50781 and 1221934-2018-50782.

Manufacturer Narrative

Evaluation statement: the complaint device is not being returned, therefore is unavailable for a physical evaluation.A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without 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 of any kind for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.However, 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.Udi: (b)(4).This report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.Corrected data: this complaint was inadvertently incorrectly reported as a serious injury.This complaint is a part of mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.This will be reported as a malfunction.Please see also medwatch report 1221934-2018-50781 and 1221934-2018-50782.

• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7626835
• MDR Text Key: 111939806
• Report Number: 1221934-2018-50783
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 10886705001828
• UDI-Public: 10886705001828
• Combination Product (y/n): N
• PMA/PMN Number: K915889
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/01/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2017
• Device Catalogue Number: 212034
• Device Lot Number: 3623409
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other