MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX ADVANCE BR W/OC&ND; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222299
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2015
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 visual observation confirms the distal tip of the anchor is broken, but is held in place by suture.The anchor appears to be used and there are evidence of tissue debris found on the anchor and the tip of the shaft.This type of anchor breakage at its distal tip is consistent with historical investigations in which it was determined that the root cause was likely a combination of torque and bending, a user technique issue.Other than this possibility, we cannot discern a root cause for this failure.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.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) complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by a nurse that there was an anchor fault.The anchor broke while being inserted, it was removed and another one was successfully inserted.There was minimal delay to the procedure - 3-4 minutes.

• Brand Name: 5.5 HEALIX ADVANCE BR W/OC&ND
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7852871
• Report Number: 1221934-2018-54313
• Device Sequence Number: 1980996
• Product Code: MAI
• UDI-Device Identifier: 10886705021352
• UDI-Public: 10886705021352
• 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: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/23/2015

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: 222299
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2015
• Initial Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1