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

Catalog Number	222233
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/23/2013
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 3 complaint devices was received and evaluated.Visual observation confirms the distal tip of the anchor is broken, but is held in place by the suture, thus confirming this complaint.There is slight tissue debris lodged between the inserter shaft and anchor on all the 3 devices.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 while inserting the anchor into the bone and also the bone quality.Other than this possibility, we cannot discern a root cause for this failure.A batch review was 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 was processed without incident and therefore there is no internally assignable cause for the reported problem.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.(b)(4).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 our affiliate the anchor broke when screwed into the bone.Three additional anchors were used.Three (3) of the four (4) anchors used broke when screwed into the bone.The procedure was completed with like product.Please see also medwatch reports 1221934-2018-50888 and 1221934-2018-50890.

• Brand Name: 5.5 HEALIX BR ANCHOR W/OCORD
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7918083
• Report Number: 1221934-2018-50889
• Device Sequence Number: 2269710
• Product Code: MAI
• UDI-Device Identifier: 10886705007790
• UDI-Public: 10886705007790
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2013

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: 11/30/2014
• Device Catalogue Number: 222233
• Device Lot Number: 3578941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2013
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2013
• Initial Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1