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	09/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The complaint devices are not being returned, therefore unavailable for physical evaluations.A review into the depuy synthes mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.However, depuy synthes mitek will continue to track any related complaints within these devices' 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 1 of 2 for the same event.It was reported by the sales rep that during a rotator cuff surgical procedure, it was observed that the tip of two of the customer's healix br anchors 3.4mm devices broke at the end of the inserter during insertion.The sales rep stated that the surgeon removed the broken tips from the patient with no further issues.The sales rep stated that there was no debris left in the patient.The sales rep reported that the surgeon completed the procedure by using a peak anchor and using the same bone hole with no patient consequences but there was a minute delay.The sales rep stated that the bone quality of the patient was normal.The sales rep stated that the devices were discarded by the facility.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: 8264151
• Report Number: 1221934-2018-52458
• Device Sequence Number: 2357720
• Product Code: MAI
• UDI-Device Identifier: 10886705023820
• UDI-Public: 10886705023820
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/02/2016

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 Expiration Date: 07/31/2018
• Device Catalogue Number: 222343
• Device Lot Number: 3860919
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2016
• Initial Report FDA Received Date: 01/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1