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

Catalog Number	222287
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2013
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIODEGRADABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7630524
• Report Number: 1221934-2018-50820
• Device Sequence Number: 13927975
• Product Code: MAI
• UDI-Device Identifier: 10886705020393
• UDI-Public: 10886705020393
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2013

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2015
• Device Catalogue Number: 222287
• Device Lot Number: 3595259
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2013
• Initial Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1