MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX ADVANCE KNTLSS BR; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 222331

Device Problem Migration or Expulsion of Device (1395)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 12/20/2016

Event Type  malfunction  

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 is not being returned, therefore unavailable for a physical evaluation.A review into the depuy 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.A device history 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; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.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.Udi: (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 Description

It was reported during a rotator cuff procedure the healix advance knotless br 5.5 mm did no hold and came out of the pre-fabricated hole.The case was completed using a like device in the original bone hole.There was a 3-minute delay in surgery and there was no patient consequence.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If additional information should become available, a supplemental medwatch will be submitted accordingly.Correction: h4: device manufacture date: the device manufacture date was inadvertently missed in the initial report and has been updated as 8/12/2016.H8: the usage of device was inadvertently missed in the initial report and has been updated accordingly.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.

• Brand Name: 5.5 HEALIX ADVANCE KNTLSS BR
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8288598
• MDR Text Key: 136860417
• Report Number: 1221934-2018-53105
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705023479
• UDI-Public: 10886705023479
• Combination Product (y/n): N
• PMA/PMN Number: K130917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 12/20/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 222331
• Device Lot Number: 3919749
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/20/2016
• Initial Date FDA Received: 01/30/2019
• Supplement Dates Manufacturer Received: 01/31/2019
• Supplement Dates FDA Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1