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

Catalog Number	222232
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2014
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: the complaint device was received and evaluated.Visual observation confirms the anchor is broken in half and the distal end is broken as well.Anchor breakages are typically associated with off axis insertion, levering during insertion, hard bone quality or using incorrect instrumentation for preparing bone hole.No information was provided on how the hole was prepared.The root cause can be a combination of the above mentioned issues.Furthermore, no lot numbers were provided which precludes conducting a batch history review or a lot specific search in the complaints handling system.At this point in time, no further action is warranted.If additional information is made available to mitek complaints in future, this complaint will be re-opened and re-evaluated.Depuy 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)-incomplete.The lot number is currently unavailable.This report is being filed from the remetrex 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 affiliate in (b)(6) that during rotator cuff repair surgical procedure, it was observed that the healix br anchor, 5.5 mm - w/orthocord & needles device broke while screwing in.It was reportedly not off-axis, bone structure normal to hard.There was a delay of 15 minutes.It was reported that the device was able to be removed.It was not reported if a spare device was available for use.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: HEALIX BR ANCHOR, 5.5 MM - W/ORTHOCORD & NEEDLES
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7840917
• Report Number: 1221934-2018-54287
• Device Sequence Number: 1431367
• Product Code: MAI
• UDI-Device Identifier: 10886705007783
• UDI-Public: 10886705007783
• 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
• Type of Report: Initial
• Report Date (Section B): 11/11/2014

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: 222232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2014
• Initial Report FDA Received Date: 09/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1