MAUDE Adverse Event Report: DEPUY MITEK LLC US HEALIX BR 3.4MM; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222343
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4) - incomplete.The exp date is currently unavailable.The complaint device was received and evaluated.Visual observation confirms the distal tip of the anchor is cracked, but is held in place by suture.When observed under magnification, no structural anomalies were observed that could have contributed to this failure.Anchor breakages are typically associated with off axis insertion, levering during insertion, hard bone quality or using incorrect instrumentation for preparing bone hole.Other than this possibility, we cannot discern a root cause for this failure.This complaint can be confirmed.A review into the mitek complaints system revealed no other complaints for the lot number of this device.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes 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.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
This is report 2 of 2 for the same event.It was reported by the sales rep that during a rotator cuff repair surgical procedure, it was observed that the two healix br 3.4mm anchor devices in the customer's two healix transcend (br/1) ds kits were cracked.The sales rep stated that while the surgeon was inserting the anchors it was noticed through the camera that there is a crack on both devices and that the metal inserter is showing.The sales rep stated that the pre-cannula worked fine.The sales rep stated that the cracks are not visible to the eye without a magnifying glass.The sales rep stated that the surgeon stated that the cracks may have been there prior to being used.The sales rep reported that the surgeon completed the procedure with a third like device using the same bone hole which cracked also while inserting, but the surgeon pulled on the anchor and the anchor stayed in position.The sales rep stated that the surgeon was ok with the end results.The sales rep reported that there were no patient consequences, but there was a five minute delay in the procedure.The sales rep stated that the anchors have two different lot numbers and that the kits are from the same lot number.The sales rep was not present for the case therefore could not provide any further information.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 3.4MM
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8253512
• Report Number: 1221934-2019-56017
• Device Sequence Number: 2434698
• Product Code: MAI
• UDI-Device Identifier: 10886705023820
• UDI-Public: 10886705023820
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2015

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 Catalogue Number: 222343
• Device Lot Number: 3814827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2015
• Initial Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1