MAUDE Adverse Event Report: DEPUY MITEK HEALIX ADVANCE BR 6.5 MM - W/ORTHOCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222300
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2013
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.Further, a review into the depuy mitek complaints system revealed no other complaints of any kind for this lot 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 or Problem Description
This is report 2 of 2 for the same event.It was reported by the affiliate in australia that during rotator cuff repair surgical procedure, it was observed that after the anchor was inserted, as the surgeon removed the inserter handle, the sutures were caught in the handle and de-threaded the anchor.The anchor was removed and discarded.A larger anchor was inserted in the same hole.After this replacement anchor was inserted and handle removed, there was a gooey substance holding the four free ends of the sutures together.Surgeon had to cut the ends of the suture to release them and continued with the procedure.It was reported that the procedure was completed successfully with a 15-minute delay.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: HEALIX ADVANCE BR 6.5 MM - W/ORTHOCORD
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7698236
• Report Number: 1221934-2018-51542
• Device Sequence Number: 996021
• Product Code: MAI
• UDI-Device Identifier: 10886705021369
• UDI-Public: 10886705021369
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K120078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2013

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: 08/01/2015
• Device Catalogue Number: 222300
• Device Lot Number: 3638665
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2013
• Initial Report FDA Received Date: 07/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1