MAUDE Adverse Event Report: DEPUY MITEK HEALIX ADVANCE KNOTLESS PEEK ANCHOR, 5.5 MM; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	222334
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2015
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.The complaint device was received and evaluated.Visual observation confirms that the same side of the fish mouth tip of the anchors is broken.The failure is consistent with pulling the suture too hard while tensioning it after inserting the anchor causing the anchor to snap and break.The sales rep reported the surgeon was using two strands of fibertape and pulled too hard causing the suture to come out of the side of the anchor.This is a user technique issue.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 synthes mitek complaints system revealed a dissimilar complaint of any kind for this lot released to distribution.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.(b)(4).This report is being filed from the etq 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 the sales rep reported that during a rotator cuff repair surgical procedure, it was observed that a healix advance knotless peek anchor, 5.5mm broke when the surgeon was loading the suture.The sales rep reported that the surgeon was using two strands of fibertape and pulled too hard causing the suture to come out of the side of the anchor.The surgeon completed the procedure with another like device with no patient consequences or delays.All available information has been disclosed.If additional information should become available, a supplelmental medwatch will be submitted accordingly.

• Brand Name: HEALIX ADVANCE KNOTLESS PEEK ANCHOR, 5.5 MM
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7678252
• Report Number: 1221934-2018-50738
• Device Sequence Number: 16355734
• Product Code: MBI
• UDI-Device Identifier: 10886705023486
• UDI-Public: 10886705023486
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K130539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/30/2015

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 Expiration Date: 09/30/2016
• Device Catalogue Number: 222334
• Device Lot Number: 3731705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2015
• Initial Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1