MAUDE Adverse Event Report: DEPUY MITEK LLC US 6.5 HEALIX ADVANCE KNTLSS BR; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222332
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 synthes 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 (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.(b)(4).
Event or Problem Description
It was reported that the 6.5 healix advance failed during an unknown procedure due to the suture bridge of the additional thread of the anchor breaks and makes the suture made with this thread unnecessary.This happened as soon as the surgeon solicits too much the thread, or makes a strong tension.The case was completed using another like device.There were no adverse patient consequences nor time delays.

• Brand Name: 6.5 HEALIX ADVANCE KNTLSS BR
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8285617
• Report Number: 1221934-2019-56219
• Device Sequence Number: 1991662
• Product Code: MAI
• UDI-Device Identifier: 10886705023493
• UDI-Public: 10886705023493
• Combination Product (Y/N): N
• PMA/510(K) Number: K131974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2016

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: 222332
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2016
• Initial Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1