MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.75 HEALIX ADVANCE KNTLSS PK; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	222333
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2016
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.(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.The complaint device was received and evaluated.Visual observations revealed that the threads on the distal tip of the anchor are deformed, confirming this complaint.Additionally, the suture is severed and the suture bridge is missing.This effect has been typically observed due to excessive tension being placed on the sutures during anchor deployment which is consistent with the observed failure on this complaint anchor.Further, a review into the mitek complaints system revealed no other complaints for this lot of devices that was released to distribution.At this point, 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.
Event or Problem Description
It was reported that during a rotator cuff repair that the surgeon threaded six sutures through the nose of their healix advance knotless peek anchor breaking it apart.The surgeon completed the procedure with another like anchor with no patient consequences or delays.

• Brand Name: 4.75 HEALIX ADVANCE KNTLSS PK
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8274864
• Report Number: 1221934-2018-51332
• Device Sequence Number: 158985
• Product Code: MBI
• UDI-Device Identifier: 10886705023455
• UDI-Public: 10886705023455
• Combination Product (Y/N): N
• PMA/510(K) Number: K130539
• 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): 02/26/2016

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: 222333
• Device Lot Number: 3865320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2016
• Initial Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1