MAUDE Adverse Event Report: DEPUY MITEK LLC US 6.5 HEALIX PEEK ANCH W/ OC; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222221
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 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.However, 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.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 affiliate in (b)(6) that during shoulder arthroscopy surgical procedure, it was observed that two stitches of 6.5 healix peek anch w/ oc suture device broke inside the patient.According to the reporter, no instrument came into contact with the suture to cause breakage.It was further reported that the surgeon put the implant but no suture because it had been broken.It was reported that the surgeon was satisfied with the fixation.It was reported that the procedure time was extended 30 minutes.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: 6.5 HEALIX PEEK ANCH W/ OC
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8267642
• Report Number: 1221934-2018-52894
• Device Sequence Number: 16736754
• Product Code: MAI
• UDI-Device Identifier: 10886982156532
• UDI-Public: 10886982156532
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 11/24/2016

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: 09/30/2018
• Device Catalogue Number: 222221
• Device Lot Number: 3865710
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2016
• Initial Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1