MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.75MM HEALIX KNOTLESS PEEK; SOFT-TISSUE ANCHOR, NON-BIODEGRADABLE

Catalog Number 222287

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2013

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The batch review 3595259 showed that the devices were conformed to in process and finished goods specifications when released to stock the 20 feb.2012.Expiration date: 2015-02 (according to retained labels).Non-conformance was opened relating to label change after ce approval with no link with this complaint.Evaluation statement: the complaint device is not being returned, therefore is unavailable for a physical evaluation.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.Therefore, we cannot determine what caused the user to experience the reported event, 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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that after surgeon inserted the anchor, on removal of inserter handle the anchor pulled out.The surgeon used competitor anchor to complete the repair.The complaint device was discarded.

• Brand Name: 4.75MM HEALIX KNOTLESS PEEK
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIODEGRADABLE
• 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: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7630524
• MDR Text Key: 112561917
• Report Number: 1221934-2018-50820
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705020393
• UDI-Public: 10886705020393
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/16/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2015
• Device Catalogue Number: 222287
• Device Lot Number: 3595259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2013
• Date Device Manufactured: 02/20/2012
• 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