MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX PEEK ANCH.W/OCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222209
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/25/2016
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 exp date is currently unavailable.The complaint device was received and inspected.Visually, the device appears to be in unused condition and no anomalies were noted on the device.This complaint cannot be confirmed.A review into the depuy mitek complaints system revealed no other complaints of any type for this lot of devices that were released to distribution.At this point in time, no corrective action is required and no further action is warranted.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
It was reported by the sales rep that during a rotator cuff repair surgical procedure, it was observed that the customer's healix 5.5mm peek anchor with orthocord broke upon insertion.The sales rep reported that the broken anchor was fully removed.The surgeon completed the procedure with another like anchor in the same bone tunnel with no patient consequences or delays.The sales rep reported that the anchor broke due to user technique.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: 5.5 HEALIX PEEK ANCH.W/OCORD
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8257775
• Report Number: 1221934-2018-51482
• Device Sequence Number: 2306981
• Product Code: MAI
• UDI-Device Identifier: 10886705007578
• UDI-Public: 10886705007578
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/25/2016

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 Catalogue Number: 222209
• Device Lot Number: 3850494
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2016
• Initial Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1