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	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2016
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.The complaint device was received and evaluated.Visual observation confirms the distal tip of the anchor is broken, but is held in place by suture.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.Further, a review into the mitek complaints system revealed no other complaints of any type 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, 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.No nonconformances were identified for this part-lot number combination per (b)(4) query executed 11/08/2018.Review conducted per (b)(4).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 surgeon intended to pull the sutures through the anchor, the tip of the anchor broke.The patient didn't experience any adverse event, and we could perform the surgery without any further issue with a new anchor.

• 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: 8282512
• Report Number: 1221934-2019-56173
• Device Sequence Number: 1672784
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 222332
• Device Lot Number: 3832001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2016
• Initial Report FDA Received Date: 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1