MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIXADV BR 5PK-3SUTURE; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/07/2015
Type of Reportable Event	Malfunction
Additional 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.Furthermore, a lot review was not available in spite of three requests sent out to the supplier.Further, a review into the depuy mitek complaints system 2012-2015 revealed no similar complaints for this lot of devices that were 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.(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 or Problem Description
The sales rep reported that the customers healix advanced 4.5mm anchor broke upon insertion as the patient had hard bone matter.The surgeon completed the procedure using another like device with no delay and no consequences.

• Brand Name: 4.5 HEALIXADV BR 5PK-3SUTURE
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7749908
• Report Number: 1221934-2018-53497
• Device Sequence Number: 1171147
• Product Code: MAI
• UDI-Device Identifier: 10886705021482
• UDI-Public: 10886705021482
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K120078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2015

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 Catalogue Number: 222320
• Device Lot Number: 3750998
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2015
• Initial Report FDA Received Date: 08/05/2018
• Patient Sequence Number: 1