MAUDE Adverse Event Report: DEPUY MITEK GLL QUICK ANCHOR PLUS #2 EXCEL ETHIBOND CP-2; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 212034

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2014

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.The complaint device was received and evaluated.Visual observation reveals no anomalies with the inserter.The anchor was not sent back and left in the patient.The ethibond suture is frayed and cut as reported.This complaint can be confirmed.It was reported that the suture broke, when moderate tension was being applied on the suture.We cannot discern a root cause for this failure mode.Based on the complaint rate and customer impact, we believe this to be an anomaly.A batch record review has been conducted and 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 type for this lot released to distribution.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.

Event Description

It was reported by the affiliate in (b)(6) that during an unspecified surgical procedure, it was observed that the orthocord suture of the anchor ruptured after applying moderate tension during knotting.The defect anchor could not be removed from patient.With same like product.It was reported that the procedure was extended for 25 minutes.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: GLL QUICK ANCHOR PLUS #2 EXCEL ETHIBOND CP-2
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7726190
• MDR Text Key: 115376692
• Report Number: 1221934-2018-52686
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 10886705001828
• UDI-Public: 10886705001828
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K915889
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2018
• Device Catalogue Number: 212034
• Device Lot Number: 3732963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2014
• Date Manufacturer Received: 10/01/2014
• Date Device Manufactured: 11/14/2013
• 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